Risk management plans are an increasingly common feature of new drug approvals, and Congress seems set on making them a standard part of the FDA review process. Industry seems willing to go along, accepting some more restricitions on new products in exchange for restoring confidence in drug safety. There is only one problem: FDA is not so sure this is a great idea.
By Michael McCaughan
Everyone seems to agree that risk management programs are a big part of the answer to resolving concerns about the...
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Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
