FDA is only mentioned once in the document, and its temporary leadership may not be the reason why.

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

The AZ vaccine is now under EU scrutiny over capillary leak syndrome, while Valneva has reported positive results with its product. The global COVAX initiative has delivered more than 38 million doses of vaccines to over a hundred countries. 

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

As MACPAC moves toward formal recommendations, a CBO analysis finds that differential Medicaid rebates for drugs approved through the accelerated pathway could save the federal government up to $1bn over five years.

Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.

Clinical trial disclosure compliance must include identification and documentation of registry requirements, key stakeholders, company policies, systems, and processes.

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.

New comprehensive study of drug coupons offered by manufacturers, pharmacies, pharmacy benefit managers and state programs, and who uses the discounts, takes a more holistic look at patient assistance programs than previous work. Researchers raise concerns that the offsets don’t seem well targeted at people with high financial or clinical need. 

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

Tax hike would fund $30bn for pandemic preparations and billions more for biotech R&D and rural manufacturing jobs that are part of comprehensive infrastructure renewal proposal.