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CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
The FDA will move to close a loophole in the program to foster study of treatments for rare pediatric illnesses, agency commissioner Scott Gottlieb said in a blog post. Read More
Galena Biopharma agreed to pay more than $7.5 million to settle a whistleblower suit alleging the drugmaker violated the False Claims Act by paying doctors to prescribe its fentanyl-based drug Abstral. Read More
Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Read More
FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference. Read More
The state of Maryland defended its law against generic drug price gouging in court, moving to dismiss a complaint brought by the industry’s trade group, the Association for Accessible Medicines. Read More
AbbVie filed a federal lawsuit in Delaware claiming Boehringer Ingelheim is illegally infringing on patents in its development of a Humira biosimilar. Read More
In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any eligible products and Orange Book changes involving their products by the end of August. Read More