Drugs
FDA has cleared an Abbott 510(k) for its Assert-IQ insertable cardiac monitor (ICM) for diagnosing and long-term monitoring of people experiencing irregular heartbeats (arrhythmias). ICMs are small devices with sensors inserted just under the chest’s skin to provide constant, real-time monitoring of a person’s
Devices
Draeger Medical has recalled its Seattle PAP Plus continuous positive airway pressure device and VentStar breathing components due to breathing circuit concerns. “Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces,” a recall notice says. FDA has determined
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations.” The document addresses selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such
FDA Policy/General
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Drug Development: Regulatory Considerations — Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act.” The document describes the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity
Drugs
The Give Kids a Chance Act, legislation that would provide children greater access to cancer trials and therapies, has been reintroduced by Reps. Anna Eshoo (D-CA) and Michael McCaul (R-TX). It has 12 bipartisan cosponsors. A statement (includes a link to the bill text) from Eshoo says the
Drugs
House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) says the committee’s minority staff is working with FDA and the White House to address the shortage of the cancer drugs carboplatin and cisplatin and implement long-term solutions to prevent the shortages from occurring in the future.
Drugs
FDA has published 46 new or revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. A notice says the latest batch includes 25 new and 21 revised PSGs; 34 PSGs for products with no approved ANDAs (including 19 complex products); 13
FDA Policy/General
The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies slashed $600 million (8.3%) from the Biden administration's 2024 proposed budget for FDA. The spending bill, which now moves to the full committee, provides $3.5 billion in direct budget authority, and
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 5/18 voted 14-0 that a Pfizer BLA demonstrated effectiveness for its Abrysvo (RSVpreF) vaccine for preventing respiratory syncytial virus (RSV) in infants from birth through six months by active immunization of pregnant individuals. A separate vote of 10-4
Drugs
FDA has published two draft guidances that when finalized will provide recommendations to support the approval of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The two documents revise and replace a previous draft guidance. The
Drugs
FDA has modified a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of the drug. “The FDA is also allowing new participant enrollment for AOC 1001
Drugs
ICU Medical has recalled the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier. Affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier than
FDA Policy/General
Federal Register notice: FDA is making available its annual compilation of notices of updates to the agency’s antimicrobial test interpretive criteria Web page with updates made in 2021 and 2022. The Susceptibility Test Interpretive Criteria Web page was established in 2017 to provide updates on the susceptibility test interpretive
FDA Policy/General
Federal Register notice: CDRH is announcing a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on advancing health equity in medical devices. The Center says technology, including digital health technology, may help bridge gaps in health equity by extending access and bringing healthcare to patients
Drugs
FDA is asking the Gastrointestinal Drugs Advisory Committee to weigh the benefits and risks of Intercept Pharmaceuticals’ obeticholic acid (OCA) to treat pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In a briefing document released in advance of the committee’s 5/19 meeting, agency medical reviewers say there
Drugs
Bipartisan legislation to use penalties paid by drug, cosmetic, supplement, and medical device companies to increase childhood cancer research has been introduced by Sens. Tim Kaine (D-VA), Jerry Moran (R-KS), and Mark Warner (D-VA). A version of the bill has also been introduced in the House by
FDA Policy/General
FDA commissioner Robert Califf says he’s cautiously optimistic that the U.S. could be on the verge of seeing major impacts from new drugs for treating Alzheimer’s and obesity. Presumably addressing Eli Lilly’s recent and promising news on its Alzheimer’s drug donanemab (see story) and its
Drugs
The American Economic Liberties Project and the Initiative for Medicines, Access, and Knowledge (I-MAK) say the “illegal and anticompetitive tactics used by the pharmaceutical industry to perpetuate monopolies — in the form of government-backed patents over brand drugs — and block competition from more affordable generic drugs” cost final payers
Drugs
UCB is asking FDA to reject an Apotex ANDA for fenfluramine hydrochloride oral solution that cites UCB’s Fintepla as the reference-listed drug. The UCB 5/15 petition says that to ensure that generic fenfluramine products are appropriately labeled for the life-threatening pediatric disease Dravet Syndrome (DS), the
Drugs
FDA has accepted for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura, an ADAMTS13 deficiency disorder. The ultra-rare clotting disorder is caused by a deficiency in ADAMTS13 protease, the company says, adding that the mortality rate, if left untreated,
Drugs
Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors. The company is a self-described “late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise.” Dunn was a top figure in FDA’s controversial
FDA Policy/General
In a “reverse-FOIA” case, an attorney who works for a company that is regulated by FDA and was inspected by the agency in 2022 filed suit on 5/16 in the DC federal court to block FDA from releasing the attorney’s identity in connection with the form FDA-