Prime Minister Narendra Modi will meet chief ministers of BJP-ruled States and members of the party’s parliamentary board on Sunday. The CMs of 13 States and five deputy chief ministers will be in New Delhi for a meeting called by the Niti Aayog, but will make the necessary stopover at the party headquarters after that.BJP president Amit Shah will also address the chief ministers, in the presence of senior Ministers Rajnath Singh, Sushma Swaraj, Venkaiah Naidu and Nitin Gadkari. BJP’s general secretary (organisation) Ram Lal will also be present.Development agendaAccording to senior party general secretary Bhupendra Yadav, Pime Minister Modi will ask the chief ministers to focus on the development agenda with an emphasis on the poor sections of the society.A similar meeting was held in August last year in New Delhi, an exercise started by Mr. Shah to ensure that all party-run governments follow a common agenda and focus on implementation of Central schemes.
Uttar Pradesh Chief Minister Yogi Adityanath and his deputy Keshav Prasad Maurya will resign from their Lok Sabha seats, Gorakhpur and Phulpur, in the next couple of days, and the search for candidates to be put up in these constituencies will begin in earnest. Before that, the BJP will keenly watch the State and national executive meetings of the Samajwadi Party in the next couple of weeks. The former Uttar Pradesh Chief Minister, Akhilesh Yadav, is expected to be elevated as party chief at the meetings, and a resolution setting forth the political line for the party for the 2019 elections is also likely to be passed. Future alliances may be discussed. BJP sources said they will track whether the SP and the Bahujan Samaj Party (BSP) will put up a joint candidate in Phulpur or fight the byelection separately. “As far as we can assess, it seems unlikely that a joint candidate will be put up as we don’t see the BSP gaining anything from it. It’s a seat where the Scheduled Castes may not vote with the Yadavs [the SP’s core vote bank],” a senior office-bearer of the party said. For Gorakhpur too, the party will have to cast its net wide as it will be for the first time in many years that the leadership of the Gorakhnath Math (headed now by Mr. Adityanath) will not be available as a candidate. Before Mr. Adityanath, his guru Mahant Avaidyanath used to represent this Lok Sabha constituency. “November and December will be crucial for the State government as that is when the byelections may be called, and the local bodies elections in the State are to be held,” the source said.
Even as Art of Living founder Sri Sri Ravi Shankar pitches for an out-of-court settlement in the Babri Masjid-Ram Janmabhoomi issue, he said on Wednesday that he was yet to propose a compromise formula to the stakeholders.“Once the proposal comes, we will talk,” said the spiritual guru hours after he called on Uttar Pradesh Chief Minister Yogi Adityanath at his official residence here.Sri Ravi Shankar is scheduled to visit Ayodhya on Thursday to meet the stakeholders.While there was no official word from the State government on the meeting, Sri Ravi Shankar described his visit as a “courtesy call” while talking to presspersons.He said he discussed with Mr. Adityanath various topics including “how we can bring peace in the nation, welfare of farmers, and cleanliness”.Later, in a tweet, the spiritual guru said Mr. Adityanath’s “efforts to address caste conflict, corruption and farmer issues are laudable”. This came a day after Mr. Adityanath welcomed Sri Sri Ravi Shankar’s efforts at mediation for an out-of-court settlement in the contentious issue.Mr. Adityanath on Tuesday said he welcomed the spiritual guru’s efforts, but maintained that a solution through discussion would be possible only if both parties consented to it.“Efforts at any level are welcome. But one side has always run away from the discussion table,” Mr. Adityanath said.“The problem is not that there should be talks, it is that both sides should mutually agree to hold talks [as the case is in the Supreme Court]. It can give good results but intentions should be good,” he said.Sri Ravi Shankar’s initiative to mediate in the case, however, did not get a positive response from the parties in the legal case.Sunni Board standZafaryab Jilani, representing the Sunni Central Waqf Board, dismissed Sri Ravi Shankar’s initiative saying it was done only for media attention and pointed out that there was no proposal submitted by him yet.“If he brings a solution, then there can be talks. If it is their solution that Muslims give up their claim for the Babri Masjid, it is not possible,” Mr. Jilani said.A solution through mutual consent can be reached only if both the disputing groups submit before the court their willingness to compromise, he added.The Vishwa Hindu Parishad also described the initiative as pointless, asserting that since “facts” and the Allahabad High Court judgment in 2010 had supported its claim for a Ram Mandir, any further negotiation would be irrelevant.“It is in our favour. So a Ram Mandir must be constructed at the site,” said Sharad Sharma, VHP spokesperson, adding that any negotiation could involve a climbdown by the Hindus and this was not acceptable to the outfit.After meeting Mr. Adityanath, he attended a meeting organised by the Ram Janmabhoomi Mandir Nirman Nyas, a less-known trust in Lucknow claiming to play interlocutor between the two sides.At the meeting were present representatives of the Nirmohi Akhara, a party in the suit, Digambara Akhara, Shiv Sena, Hindu Mahasabha and the Rashtriya Swayamsevak Sangh. Rajya Sabha member and founder of the Bajrang Dal, Vinay Katiyar joined them. Clerics Khalid Yusuf Azizi, Imran Hasan Siddiqui and others too were present.Referring to the various Hindu organisations assembled in his house, Amarnath Mishra, the convenor of the RJMNN, said it was the first time these leaders sat on a table to discuss the way forward for the construction of the Ram Mandir.
The Supreme Court on Friday sought a report from the CBI on photographs in which former Bihar health minister and RJD chief’s son Tej Pratap Yadav is seen posing with a proclaimed offender Mohammad Kaif.The direction came on a petition filed by Asha Ranjan, whose husband and journalist Rajdeo Ranjan was murdered in Siwan district in Bihar. Kaif is an accused in Ranjan’s murder and was absconding in the case when the photographs surfaced in the media. Kaif is alleged to be a sharp-shooter for Siwan strongman and jailed RJD leader Mohd Shahabuddin.Police investigationA Bench led by Chief Justice of India Dipak Misra directed the CBI to find out the progress made by the local police in its investigation into the photos. The court ordered Ms. Ranjan’s counsel, advocate A.R.M. Pandey, to provide the CBI counsel and Additional Solicitor General Tushar Mehta with a transcript of a press conference held by the Siwan police chief assuring investigation into the photographs. The court ordered the CBI to file a report in four weeks.”It was expedient on the part of the Siwan Superintendent of Police to file an FIR… he miserably failed to take action. Kaif is now out on bail… Both Kaif and Javed (another accused in the Ranjan case) were remanded only after the writ petition was filed in the Supreme Court,” Mr. Pandey submitted.‘Harbouring accused’The counsel submitted that serious action should be taken against Mr. Tej Pratap for “harbouring and screening” offenders.Responding to the submissions, Mr. Tej Pratap’s counsel explained that his client was attending a public function and a “man came up and gave me a bouquet of flowers”.“Nobody says that I was seen with Kaif prior to the murder,” Tej Pratap’s counsel said.
Former Chhattisgarh chief minister and president of Chhattisgarh Janata Congress party, Ajit Jogi, was shifted to New Delhi by an air ambulance and admitted to the Medanta hospital in the early hours on Wednesday.The 72-year-old Mr. Jogi was undergoing treatment at a hospital in Raipur after being diagnosed with pneumonia.The decision to immediately shift him to New Delhi was taken on Tuesday when he complained of breathlessness.“My father is currently admitted in Medanta Hospital under the care of eminent cardiologist Dr. Naresh Trehan, Dr. Yatin Mehta and his team. He was diagnosed with pneumonia and shifted by an air ambulance from Raipur last night on ventilator-support. All his vital parameters are normal now. He remains alert and conscious. Consequently, he is being weaned off ventilator support,” informed Ajit Jogi son, Amit Jogi.“His condition continues to be stable. To avoid any chance of secondary infection, the hospital is maintaining a strict no-visitors policy. He will be examined by heads of all relevant departments during the course of next 24 hours,” Mr. Amit Jogi, who is a Chhattisgarh MLA, added.Mr. Ajit Jogi had left the Congress in 2016 to form his own party. He had lost both his legs in a car accident in 2004.
Law Minister Ravi Shankar Prasad on Monday said that the government didn’t commit a “cardinal sin” if it asked for reconsideration of a name suggested by the Supreme Court Collegium and advised political parties that “lost popular franchise” not to push “sponsored litigation” in court.Mr. Prasad’s reference was to the government’s decision to return the Collegium’s recommendation to elevate Uttarakhand High Court Chief Justice K.M. Joseph as a Supreme Court judge and the Judge B.H. Loya case.In a reference to the unprecedented episode of four top judges of Supreme Court openly dissenting against Chief Justice of India Dipak Misra, the Law Minister said the judiciary had “foresight and statesmanship to settle differences within it and the political class to remain immune”.Subordinate judiciary Claiming that the government had done well to fill vacancies in higher judiciary, Mr. Prasad suggested a robust pan-India entrance test to allow talent infusion into subordinate judiciary as nearly 5,000 vacancies exist in subordinate judiciary.Reacting to charges of stalling appointments to the Supreme Court and the 24 high courts, the Law Minister said his office is not a “post office” which would only process recommendations of the Collegium on the appointment of judges.“I wish to make it very clear that the Law Minister or the Law Ministry is not a post office. This fact I would like to very gently highlight. Even in the Collegium system… created by the three judgments of 1993, 1998 and 1999, the right of the government has been acknowledged to seek a reconsideration and also to give inputs,” he said addressing an event. He said it isn’t correct to say that “we are committing a cardinal sin” by seeking a reconsideration.“In 2016, we appointed 126 HC judges, which was the highest number in the last 30 years. Since 1989, on average 79 to 82 judges were appointed (per annum). In 2016 alone, 126 judges to high courts were appointed and in 2017, 117 HC judges were appointed, and till now 30 HC judges have been appointed (this year),” he said.Without naming the Congress, he hit out at the party for using courts to settle political scores.
A special court on Monday extended the remand of Sharad Kalaskar, alleged to be the second shooter in the killing of rationalist Dr. Narendra Dabholkar, in CBI custody till September 15.Kalaskar, first arrested in connection with the Nallasopara arms haul case, was today produced in court along with Rajesh Bangera and Amit Digwekar — key suspects in the murder of journalist/activist Gauri Lankesh — in connection with the Dabholkar case on expiry of their CBI custody.While extending Kalaskar’s remand, judicial magistrate, first class, S. M. A. Sayyed sent Bangera and Digvekar to judicial custody.Arguing for an extension of their custodies, the CBI’s counsel, Vijaykumar Dhakane, submitted before the court that Bangera had trained a number of followers of the radical rightwing Sanatan Sanstha, including Dr. Virendra Tawde and Amol Kale (both prime suspects in Dr. Dabholkar’s murder), in a number of places across Karnataka and Maharashtra.“Between 2012 and 2016, Bangera had trained several Sanatan followers in Sampaje, in Belgaum, where he instructed Dr. Tawde, at Hubli, in Kolhapur, where Amol Kale was present, in Dakshin Kannada and in Pune,” said advocate Dhakane.He said that an extension of his custody was needed to find out more details of these weapon-training sessions, the source from where Bangera procured the firearms, the motive behind these training sessions and the present whereabouts of these arms.The Tawde linkArguing for extension of Digwekar’s custody, the CBI counsel submitted that he had been a close associate of Dr. Virendra Tawde (alleged to be the mastermind of the murder) and that he had been a permanent resident at the Sanstha’s headquarters in Ponda, Goa.Mr. Dhakane said the agency needed time to trace the motorcycle — a black Hero Honda — and firearms by Kalaskar and Sachin Andure (said to be the main shooter) in killing Dr. Dabholkar on 20 August, 2013.In his counter-arguments, defence counsel, advocate Dharmraj Chandel said the CBI was abusing the police custody granted to the accused by the court.“One submission common in the CBI’s remand application and case diary is that all three accused have fully cooperated with the agency. It implies that whatever could have been investigated by authorities has already been done so and there’s no point in seeking further custody,” he said.Stating that the CBI’s charges against Digwekar and Bangera were vague in nature, advocate Chandel said that Digwekar’s mere connection with the Sanatan Sanstha was not incriminating per se.“The CBI has not yet proved conclusively whether Bangera imparted training to the assailants of Dr. Dabholkar,” said Mr. Chandel.He further alleged that an official, unconnected with Dr. Dabholkar’s murder, had apparently assaulted Bangera while questioning him about the murder of Communist leader Govind Pansare.“The CBI’s interrogation of its alleged suspects seems to have no focus whatsoever. During the last day of the CBI’s custody of Sachin Andure [alleged to be the main shooter], the agency had questioned him [Andure] about the Govind Pansare murder which is being probed by the Maharashtra SIT. Why isn’t the agency focusing on the crime for which it has sought custody of the suspect?” said Mr. Chandel.Magistrate Sayyed later granted the agency an extension of Kalaskar’s custody, while rejecting the CBI’s demand for extending the custodies of Bangera and Digwekar.Both Bangera and Digwekar will now be sent back to the Central Prison in Bengaluru.Last week, the court had remanded Amol Kale — another key accused in the Gauri Lankesh case — to the CBI’s custody till September 14 in connection with the murder of rationalist Dr. Narendra Dabholkar.The agency alleged that Kale had supplied the motorbike and the murder weapon to Kalaskar and Andure. It has alleged that Kalaskar was an expert in arms manufacturing and was part of the wider conspiracy that links the murders of other rationalist-activists, Communist leader Govind Pansare and journalist Gauri Lankesh.The Maharashtra Anti-Terrorism Squad (ATS) had arrested Kalaskar along with fringe rightwing activist Vaibhav Raut from Nallasopara in Mumbai, and Sudhanwa Gondhalekar from Pune onAugust 10, for allegedly planning disruptive activities in several parts of the State.During his interrogation by the ATS, Kalaskar, a native of Aurangabad who had shifted to Kolhapur a while ago, had allegedly confessed confessed that he and Andure were the motorcycle-borne assailants who had gunned down Dr. Dabholkar.
The national flag was allegedly displayed upside down during a rally led by senior BJP leader Rajiv Jasrotia in Kathua district, following which an FIR was lodged for insulting the tricolour, police said on Saturday.The FIR was registered on Friday against unknown persons in Kathua Police Station under Section 2 (insulting the national flag or the Constitution) of the Prevention of Insults to National Honour Act, a police official told PTI. A local resident, Vinod Nijhawan, in a complaint alleged the national flag was disrespected during the rally led by Mr. Jasrotia, who is a former minister, and BJP candidate Rahul Dev Sharma, the official said.Mr. Jasrotia, who is the BJP MLA from Kathua constituency, had accompanied Mr. Sharma in a procession from his Shiv Nagar residence to file nomination papers for ward number 19 on Thursday for the Urban Local Body polls.The complainant presented a video clip purportedly showing a person, just behind the BJP legislator, holding the tricolor upside down during the procession which covered a distance of over two km, the official said.In his complaint, Mr. Nijhawan said the act was “very heinous” and hurt the “sentiments of the patriotic citizens of India”. The official said an investigation was underway in the matter.
The Punjab government has banned the sale of glyphosate, a herbicide which is extensively used in the State to control a wide variety of weeds in almost all the crops.“This chemical has been observed to be a Group 2A cancer-causing material. Besides cancer, this chemical is also known for causing other health problems and has the potential to damage human DNA as per the opinion of experts from PGIMER, Chandigarh,” said an official statement here.Glyphosate is sold in the country under various trade names such as Round-up, Excell, Glycel, Glider, Glydon, etc. The Punjab State Farmers Commission had also recommended a ban on the sale of the chemical in Punjab.State Agriculture Secretary K.S. Pannu on Wednesday said that the Central Insecticide Board and Registration Committee has recommended the use of the herbicide only for tea gardens and non-cropped areas and therefore there is a dire need for strict compliance under the Insecticides Act, 1968.“There is no cultivation of tea in Punjab and on account of 200% crop intensity in the State, the non-cropped area is too meagre. Even this small area is associated with crop cultivation in the form of ridges, water channels, bunds and between rows of crops and canal and drain banks. Therefore, even this area is part of the cropped area for all practical purposes,” he said.Immediate effect“All pesticide manufacturers, marketers and dealers in the State shall not sell glyphosate formulations-concentrations with immediate effect. The licensing authorities have been asked to take necessary steps for removal of entries for glyphosate from the licences issued by them,” he added.
A 15-year-old boy was stabbed to death after he intervened in a fight that broke out on the dance floor of a marriage function in Sunlight Colony on November 19. The accused have been arrested, the police said on Wednesday. The police said that a PCR call was received at 11 p.m. on Monday. The victim was taken to a hospital where he succumbed to his serious injuries on Tuesday morning at AIIMS.Mohit, a resident of Hari Nagar in Ashram, had come to attend a marriage function in Sunlight Colony. An argument broke out between two men — Himanshu and Arthur — after their hands brushed against each other while dancing. The argument turned ugly after which Mohit intervened. However, Himanshu and his friend Gaurav got into an altercation with Mohit, following which Himanshu stabbed Mohit in the chest. They fled after stabbing him.
Shiromani Akali Dal president Sukhbir Singh Badal on Wednesday said that Election Commission should immediately de-recognise the Congress party.“With the Delhi High Court observing that Sajjan Kumar involved in the 1984 anti-Sikh riots case had escaped the law for 34 years due to political patronage, the Election Commission must step in and take action against the Congress party,” said Mr. Badal here after holding party’s core committee meeting here.“This is a fit case to de-recognise the Congress party,” he said.Party’s core committee lauded the bravery of the witnesses who did not succumb to political pressure and pursued the cause of justice against Sajjan Kumar and others.Resolution passedA resolution was passed during the meeting condemning the Congress government for allegedly vitiating the atmosphere in the State ahead of the panchayat elections, slated for December 30.“The Congress government had murdered democracy by directing officials to function as per whims and fancies of party legislators and leaders. Though the SAD was not contesting the panchayat elections on the party symbol, party workers aligned with it were not allowed to enter government offices to file their nominations and were not being given no due certificates,” said the resolution.Mr. Badal also asked why Congress chief Rahul Gandhi was “afraid” of taking action against senior party leaders Jagdish Tytler and Kamal Nath for their alleged role in the 1984 anti-Sikh riots.(with PTI inputs)
An Indo-Tibetan Border Police (ITBP) personnel was killed and 34 others were injured Monday when a bus carrying them skidded off the road and fell into a gorge along the Jammu-Srinagar National Highway, police said. Five of the injured ITBP personnel are in a critical condition, a police officer said. The vehicle was part of a Jammu-bound convoy and the accident occurred near Khuni Nallah in Ramban district around 8.45 am, a police officer said. An ITBP personnel was killed while 34 others, including a civilian driver and conductor, were rescued and rushed to the district hospital in Ramban, the officer said. Trees prevented the bus from falling further down in the gorge, the officer said. Around 35 people were travelling in the bus.
The Army on Monday said it foiled the Pakistan Army-backed Border Action Team (BAT) attempt to strike a forward post along the Line of Control in (LoC) Nowgam area, and killed two intruders in north Kashmir’s Baramulla district on December 30.An Army spokesperson said the intruders attempted to move by exploiting the thick jungles close to the LoC and were assisted by heavy covering of fire of high calibre weapons such as mortars and rocket launchers from the Pakistani posts.“The movement was nonetheless detected by the vigilant Indian Army troops deployed along the LoC. The fire-fight initiated by Pakistan was given a strong retaliation by the Indian Army and the exchange of fire continued the whole night,” said the spokesman.The army conducted prolonged search operations in the thick jungles and difficult terrain conditions to ascertain the situation, which confirmed the killing of two intruders and recovery of a large cache of warlike stores.“The search operations are still underway to sanitise the area. It was also reported that a few other intruders managed to escape across the LoC taking advantage of adverse weather and visibility conditions,” the Army said.The Army said the intruders wore combat dresses like Pakistani regulars and carried stores with Pakistani markings. Some were seen in the Indian Border Security Force (BSF) and old-pattern Indian Army uniforms.
Five persons have been arrested on the charge of smuggling cattle and as many as 62 cattle rescued in Udhampur and Samba districts of the Jammu region, police said on Wednesday.A police team intercepted 55 cattle being taken on foot towards Kashmir without valid permission near the Sangoor Chowk on the Jammu-Srinagar National Highway in Udhampur district on Tuesday evening.The cattle were rescued and suspects Hamid Khan and Mohammad Mashboor arrested. “Two of their accomplices managed to flee and efforts are on to nab them,” a police spokesperson said.Four more cattle were rescued from the nearby Jakhani Chowk in Udhampur on Tuesday.“The driver, Ghulam Rasool, was arrested and the police seized the vehicle in which the cattle were being taken,” the spokesperson said.In another incident, two persons, Bittu Ram and Vaid Parkash, were arrested after the police intercepted a Srinagar-bound vehicle at Mansar in Samba and rescued three cattle. “These were being transported without any permission,” the spokesperson said.In the past three-and-a-half months, the police in Udhampur arrested over 100 people on the charge of bovine smuggling and rescued 662 cattle. “The police had also seized 55 vehicles used for cattle smuggling,” he added.
A move by the U.S. Food and Drug Administration (FDA) to regulate diagnostic tests developed in thousands of laboratories is picking up steam—and drawing fire. The agency recently notified Congress that it plans to regulate some of these so-called laboratory developed tests (LDTs)—which, unlike tests marketed by diagnostic manufacturers, don’t currently require FDA approval. FDA has not yet released a draft guidance on the matter, but at a hearing yesterday, members of the U.S. House of Representatives Energy & Commerce Committee’s health subcommittee raised questions about the agency’s authority to regulate these tests, its motivation for doing so, and the potential impact of such regulations on the diagnostic industry.Doctors use diagnostic tests to determine which patients are at risk for developing a disease and which would benefit from a treatment. And while companies offer FDA-approved kits for many of these uses, clinical labs often design and offer their own. According to the American Clinical Laboratory Association (ACLA), more than 11,000 laboratories are authorized to develop and perform LDTs, and the majority of them do.FDA has had the authority to regulate LDTs—and all in vitro diagnostics—since 1976, explained Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, at the hearing. But the agency has so far exercised “enforcement discretion” and has not required that labs manufacturing these tests seek its approval. Labs have instead been regulated by the Centers for Medicare & Medicaid Services through the 1988 Clinical Laboratory Improvement Amendments (CLIA).Sign up for our daily newsletterGet more great content like this delivered right to you!Country *AfghanistanAland IslandsAlbaniaAlgeriaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBolivia, Plurinational State ofBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo, The Democratic Republic of theCook IslandsCosta RicaCote D’IvoireCroatiaCubaCuraçaoCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and Mcdonald IslandsHoly See (Vatican City State)HondurasHong KongHungaryIcelandIndiaIndonesiaIran, Islamic Republic ofIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People’s Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People’s Democratic RepublicLatviaLebanonLesothoLiberiaLibyan Arab JamahiriyaLiechtensteinLithuaniaLuxembourgMacaoMacedonia, The Former Yugoslav Republic ofMadagascarMalawiMalaysiaMaldivesMaliMaltaMartiniqueMauritaniaMauritiusMayotteMexicoMoldova, Republic ofMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorwayOmanPakistanPalestinianPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalQatarReunionRomaniaRussian FederationRWANDASaint Barthélemy Saint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (Dutch part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyrian Arab RepublicTaiwanTajikistanTanzania, United Republic ofThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuela, Bolivarian Republic ofVietnamVirgin Islands, BritishWallis and FutunaWestern SaharaYemenZambiaZimbabweI also wish to receive emails from AAAS/Science and Science advertisers, including information on products, services and special offers which may include but are not limited to news, careers information & upcoming events.Required fields are included by an asterisk(*)But LDTs aren’t what they used to be, Shuren told the subcommittee. They’re manufactured in large quantities and are increasingly removed from the health care centers and doctors who order them. They are also increasingly complex, relying on sophisticated software to interpret results. Although CLIA ensures that labs perform a test properly, it doesn’t address the clinical validity of the test itself—how accurately it measures a patient’s condition. “We have a responsibility to provide patients with greater certainty,” Shuren said.That’s why FDA has for years been angling to regulate LDTs and is now developing a draft guidance for labs to seek its approval. The new requirements wouldn’t apply to all tests. Those that FDA considers “low-risk,” those that diagnose rare diseases, and those that have no FDA-approved equivalent would continue to enjoy enforcement discretion. But for the rest, labs would have to submit data proving their validity. But it’s not yet clear how many labs would be subject to the new requirements.Some lawmakers and stakeholders balk at the thought of FDA’s increased involvement. Alan Mertz, president of ACLA and a witness at the hearing, argued that the proposed regulations would discourage labs from developing innovative new tests and prevent them from adjusting the tests quickly for new uses. Mertz, along with several representatives, also challenged FDA’s authority to regulate LDTs, arguing that they are not “devices” but rather services provided to a patient, and are already regulated effectively under CLIA.But others welcome FDA’s move to raise the regulatory bar. Christopher Newton-Cheh, a cardiologist at Massachusetts General Hospital in Boston who testified on behalf of the American Heart Association, called the current system “completely opaque.” Doctors often aren’t aware if the test they order is FDA-approved, and inaccurate results increase the risk that patients will undergo unnecessary treatment or be excluded from a treatment based on bad information. “This is the right thing to do for patients,” he said.FDA may release its draft guidance on or after 29 September. Once the agency finalizes the guidance, it intends to phase in the new review process over 9 years.