This Week at FDA: ASCA guidances, new clinical trial guidances, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA issued three draft guidances for its Accreditation Scheme for Conformity Assessment (ASCA) program, three clinical trial guidances, and announced the continuation of an ongoing pilot.On Friday, FDA issued three draft guidances related to ASCA: a general guidance discussing the goals and implementation of the program, a guidance focused on biocompatibility testing standards, as well as a guidance discussing basic safety and essential performance-specific standards.
Earlier this week, FDA issued three guidances addressing different issues related to clinical trials, including a final guidance on decentralized clinical trials, and draft guidances addressing multiregional trials in oncology and incorporating randomized controlled trails into routine clinical practice.
The agency also announced the continuation of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) into its third year. The program is intended to expedite the CMC development of products under an investigational new drug application (IND) and features increased communication between sponsors and the agency. FDA says it will begin accepting requests to participate for the next year of the program on 1 October 2024.
Reuters reports that the 5th Circuit Court of Appeals has revived a case, brought by the pharmaceutical lobby group PhRMA, challenging the legality of Medicare drug price negotiations.
Shortly after pharmacy benefit manager (PBM) Express Scripts sued the Federal Trade Commission (FTC) over a recent drug pricing report that found PBMs increase the cost of drugs in the US, STAT News reports that the FTC is suing the three largest PBMs and their group purchasing organizations over “anticompetitive practices” that inflated the price of insulin.
On Wednesday, the House Energy & Commerce committee advanced the Give Kids a Chance Act of 2024 to the full House for consideration; notably, the bill would reauthorize FDA’s rare pediatric disease priority review voucher program, which is set to expire at the end of the month, for five more years.
Drugs & biologics
This week, FDA announced several notable drug approvals, including the approval of Zevra Therapeutics’ Miplyffa (arimoclomol) as the first treatment for Niemann-Pick disease and the expanded approval of MedImmune’s FluMist (influenza vaccine live, intranasal) to enable self- or care-giver administration.
FDA also approved Janssen’s Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed to treat adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations and whose disease has progressed following treatment with an EGFR tyrosine kinase inhibitor, as well as Merck’s Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy as a first-line treatment for pemetrexed and platinum chemotherapy, as well as Novartis’ Kisqali (ribociclib) with an aromatase inhibitor and Kisqali Femara Co-Pack (ribociclib and letrozole) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
FDA issued a warning to consumers advising them not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to the risk of microbial contamination. FDA said it has asked the company to recall the product twice since an inspection in April 2024 “uncovered laboratory test results that reported significant microbial contamination,” though it has so far refused to do so.
Medtech
FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research have issued a new draft guidance offering recommendations on chemical analysis for the biocompatibility assessment of medical devices.
FDA’s announced this week that its Digital Health Advisory Committee will meet on 20-21 November to discuss total product lifecycle considerations for generative artificial intelligence (AI)-enabled medical devices.
The US Attorney’s Office for the Eastern District of Pennsylvania announced that medical device distributor Azon Medical, LLC will pay more than $1 million to resolve its liability under the False Claims Act for allegedly causing improper billing for peri-auricular stimulation (P-stim) devices to Medicare in 2016.
FDA announced several class I medical device recalls this week, including the recalls of Smiths Medical’s ParaPAC Plus Ventilators due to the risk of loosened or detached patient outlet connectors, various B. Braun Medical infusion systems and pumps, and certain Fresenius Kabi Ivenix Large Volume Pump Primary Administration Sets.
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