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A new congressional report has concluded that the drug industry’s increasing investment in R&D is not resulting in sufficient increases in the new drug pipeline and structural changes are necessary to fix a “stagnant” system.
A joint FDA advisory committee recommendation of narrower indications for, and increased warnings on, sanofi-aventis’ antibiotic Ketek has the company taking steps to respond as a competitor may begin grabbing market share.
Members of a joint advisory committee voted to slash the approved uses for sanofi-aventis’ antibiotic Ketek and place a black box warning on its remaining indication.
The FDA may be facing increasing pressure on Capitol Hill due to its handling of Ketek, as a former agency official turned whistleblower is working with activists and a key Senate critic to take the FDA to task.
In an interview with WDL, a top FDA official defended the agency from allegations of misconduct levied by frequent agency critic Sen. Chuck Grassley (R-Iowa).
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late last week.
In an interview with DID, a top FDA official defended the agency from allegations of misconduct levied by frequent agency critic Sen. Chuck Grassley (R-Iowa).
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a consultation paper seeking comments on a proposed hike in industry fees for activities related to the regulation of drug products.
The FDA is planning to expand its black box warning for all antidepressants to warn that young adults using these drugs face a greater risk of suicidality, the agency announced late yesterday.