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A 10-item Form 483 called out multiple problems with expired or non-pharmaceutical grade products, lack of written procedures and records, and an inadequate quality control unit at Maryland-based Aerosol and Liquid Packaging. Read More
NDAs, ANDAs and BLAs need to incorporate risk evaluation and mitigation strategies (REMS) with clear goals, objectives, and strategies that align with the intended outcomes not only for the design of the REMS but also for future modification, a new FDA draft guidance says. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, thathas been acted on since Oct. 1, 2023 to keep you updated on laws andregulations that could impact your business. Read More
The overall quality of data and risk of potential bias in them should be top of the mind for European sponsors who want to employ real-word data (RWD) in non-interventional studies (NIS), according to a reflection paper released by the European Medicines Agency. Read More
The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Sciences (OTS), highlighting activities that span dozens of drug approvals and guidances from developing AI-enabled software prototypes to identify adverse drug events. Read More
In this edition of Quick Notes are drug approvals to treat hemophilia B, rare genetic disorder WHIM, cervical cancer, cluster seizures in children with epilepsy and a new formulation of a drug for movement disorders. Read More
This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA labeling statements, use of human- and animal-derived materials in the manufacture of CGT and TEMP products, safety testing of human allogeneic cells. Read More
Using Sarepta’s treatment for Duchenne muscular dystrophy (DMD) as an example, a researcher from the Institute for Clinical Review (ICER) said in a recent article that the FDA should be cautious in granting full approval to drugs that fail confirmatory tests. Read More
“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of Internal Medicine. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More