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The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma compan | The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma company in April.
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The FDA has hit QOL Medical with an untitled letter over emails about Sucraid, accusing the company of creating a misleading…

FDA paused public release of pharma rejection letters (CRLs) after a law firm's April citizen petition. Last published CRL was…

The FDA has delayed a decision on the approval of AstraZene | The FDA has delayed a decision on the approval of AstraZeneca’s…

From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with…

Pfizer’s complaint about Alnylam’s activities at a cardiology congress has led the PMCPA to chastise the | Pfizer’s complaint…

In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has

Clinical Success Is No Longer One Number