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The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More
Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric Advisory Committee (PAC) on Tuesday. Read More
The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance that also includes several clarifications. Read More
ARS Pharmaceuticals announced that the FDA issued a complete response letter (CRL) on its NDA for neffy (epinephrine nasal spray) after having received a recommendation for approval from the agency’s Pulmonary-Allergy Drugs Advisory Committee in May. Read More
CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the effort to reduce redundant expectations and requirements among international regulatory bodies. Read More
Despite impressive gains in recent years, investment in gene therapy products is at a critical juncture due to current manufacturing challenges, among other factors, says Peter Marks, director of CBER, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Tuesday. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More
While the U.S. has seen a decrease in the number of shortages, the country has seen an increase in the complexity of shortages and the time necessary to mitigate these shortages, warns Patrizia Cavazzoni, director of the FDA’s CDER, speaking at the 2023 PDA/FDA Joint Regulatory Conference. Read More
Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open forum held by the Alliance for a Stronger FDA. Read More
Pandemics. War. Political upheaval. Severe weather. Availability of energy supplies. Any of these can kink up the supply chain, making it difficult (and sometimes impossible) to get drugs to the patients who need them, said Dionne Dosa, executive director of CMC Procurement for Moderna. Read More
Celgene and Bristol Myers Squibb (BMS) have used a pattern of unlawful patents to extend a monopoly in the market for Pomalyst (pomalidomide), a blockbuster drug used in the treatment of multiple myeloma, according to a lawsuit filed by Blue Cross and Blue Shield of Louisiana (BCBS). Read More
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI). Read More