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Latest From Brenda Sandburg
US FDA Puts Spotlight On Alkermes' Violative Vivitrol Ad
The apparently first-ever FDA press release for an advertising warning letter underscores importance of opioid issues – and the agency’s changing approach to media relations in general. FDA objects to Alkermes journal ad that excludes risk information about its opioid dependence treatment drug.
Biologic Exclusivity Provision In USMCA Is Boon To Generics Industry; BIO Is 'Tremendously Worried'
Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.
US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says
Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.
US FDA's Office Of New Drug Leaders Listen To Stakeholders
US Supreme Court Seems Poised To Allow Patent Holders More Judicial Review Options
In case that could impact challenges of biopharma patents, Supreme Court questioned the consequences of not allowing courts to review PTAB institution decisions when petition may be time barred.