FDA has not received more than 49 ANDAs in a single month since the June 2014 rush.
FDA’s vacation from an elevated level of new ANDA submissions continued through the start of 2015, but so far it has not translated into a dramatic increase in approvals.
Generic sponsors still may be recovering from their massive push to get submissions to the agency last summer ahead of...
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.
The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.
