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).…
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…
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…
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…
The Environmental Protection Agency (EPA) must complete its work on the final rule governing commercial sterilization using ethylene oxide (EtO) by March 1, 2024, following the government’s signature on a…
Despite customers’ reporting symptoms that included stroke, memory loss, atrial ffibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home electroconvulsive therapy (ECT) device, the company did not submit the…
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. Source:…
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…
The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than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 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…