Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
Four Republican senators are pressing FDA about charges from industry that the agency is using draft guidance documents to make substantive policy changes.
The lawmakers want information from FDA on guidelines that currently remain in the draft stage, the agency’s plans for finalizing...
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The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
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.
