Drugs
Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) have introduced bipartisan legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA handles orphan drug exclusivity (see earlier story). A House Energy and Commerce Committee bill (see story)
FDA Policy/General
Senate Health, Education, Labor and Pensions Committee chair Patty Murray (D-WA) and ranking member Richard Burr (R-NC) have released a discussion draft of a bill that would reauthorize FDA user fee programs for another five years and enhance certain other program areas, like the regulation of diagnostic tests
Drugs
FDA has accepted for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy (IgAN). The company says it is seeking accelerated approval, and, if approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy. The agency has set an
FDA Policy/General
Federal Register notice: FDA is debarring for five years Howard Stanley Head from importing or offering for import any drug into the U.S. In 11/2021, Head was convicted of conspiracy to import misbranded prescription drugs, under his business “Dr. Head’s Meds.” To view the notice, click here.
Drugs
FDA has released a revised final guidance entitled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” The document discusses how to investigate OOS test results, including the roles/responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the
Devices
Avanos Medical has recalled (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced. The device is intended to help with the placement of such tubes, but if a nasogastric or nasoenteric tube is inserted incorrectly,
Devices
FDA 5/16 issued an Emergency Use Authorization (EUA) for the Labcorp’s Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test. It is the first Covid-19 direct-to-consumer test that also detects and differentiates influenza A
Drugs
FDA has removed a clinical hold on Gilead Sciences’ injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis. The company previously announced that the agency hold was placed on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. “FDA removed the clinical hold following
Drugs
A March FDA inspection of Novel Laboratories (dba Lupin Somerset) has resulted in a 13-item FDA Form-483. A 2020 agency inspection at the Novel facility led to a 6/11/21 Warning Letter citing three significant violations of current good manufacturing practice regulations for finished drugs. In the
Drugs
FDA has rejected an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and other researchers to allow the use of generic drug fluvoxamine maleate for outpatient treatment of Covid-infected adults to prevent progression to severe disease or hospitalization. Fluvoxamine is currently
FDA Policy/General
HIV Tests Down Classified to 510(k) 05/13/2022 Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF,
FDA Policy/General
DEVICES FDA has cleared a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine. The device features “newly designed top-loading, high angulation, polyaxial screws that provide up to 105
Drugs
Ethicon has acquired Torax Medical, which manufactures and markets the LINX Reflux Management System for treating gastro-esophageal reflux disease. The device is based on magnetic sphincter augmentation (MSA) technology and the procedure is currently available in the U.S. and European medical centers. BioLineRx Ltd. has acquired Agalimmune Ltd.
Drugs
A just-published article in the journal Nature examines the problems with FDA’s accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical industry. “Part of the problem is that drug companies aren’t upholding their end of the bargain with timely post-market studies confirming
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. The
Drugs
BridgeBio Pharma has entered into a definitive agreement with an undisclosed purchaser to sell its priority review voucher for $110 million. The voucher was awarded by FDA in 2/2021 after it approved the company’s Nulibry (fosdenopterin), for treating an ultra-rare disease called molybdenum cofactor deficiency (MoCD) Type
Drugs
FDA has issued UCB a complete response letter on its BLA for bimekizumab for treating adults with moderate to severe plaque psoriasis. The letter says preapproval inspection observations must be resolved before the submission can be approved. In 8/2021, bimekizumab received marketing authorization in the European Union and Great
Drugs
A scathing 23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India). The company announced earlier in the week that the inspectional observation form was issued 5/9 at the conclusion of its inspection, and the agency has now released the redacted
Drugs
FDA has approved an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise. “Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which
Devices
FDA has cleared a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform. The first test available on the new BD COR system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections
Devices
FDA has approved a Medtronic PMA for the Onyx Frontier drug-eluting stent (DES), indicated for treating patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The device is designed to improve deliverability and will “continue to help interventional cardiologists treat
Devices
Pharmatech Associates managing director Stephanie Gaulding says proposed revisions to FDA’s Quality System Regulation for medical devices “is a significant step toward global harmonization and reduces the amount of U.S.-specific regulations for medical device manufacturers, especially relating to structure and requirements for a medical device quality management