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The FDA issued three final guidances on Wednesday, one on the use of real-world data (RWD) in noninterventional (observational) studies and two on the Drug Supply Chain Security Act (DSCSA). Read More
Upcoming events in the coming weeks include ten 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 and medical device counterfeiting. Read More
Pharmaceutical companies directly impacted by HHS’ Tuesday announcement of the initial 10 drugs slated for Medicare price negotiations via the Inflation Reduction Act (IRA) have swiftly reacted, with many of them already fighting the law’s provisions in court. Read More
The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Read More
Pfizer announced Monday that it has reopened its Rocky Mount plant and that efforts to restart production are on track to restart production near the end of the year. Read More
HHS this morning released its list of the top 10 drugs for negotiation through the Inflation Reduction Act, a group that represents $50.5 billion in Medicare Part D prescription drug costs — 20 percent of total gross spent between June 1, 2022, and May 31. Read More
Amgen scored a win in its bid to acquire Horizon Therapeutics with the FTC withdrawing from adjudication of its challenge of the deal until Sept. 18, to allow for discussion of a possible settlement. Read More
The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than 160 comments the agency received. Read More
The FDA is seeking public comment on its decision to withdraw accelerated approval for Oncopeptide’s Pepaxto (melphalan flufenamide), after a required postmarketing study showed that the drug plus dexamethasone failed to improve progression-free survival in patients with relapsed or refractory multiple myeloma. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More