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Tag Archives: Regulatory
FDA: From Risk Aversion to Approval Activism
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news.
On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]
Posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership Also tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman 2 Comments
Safety Trumps Access to Pain Meds for FDA
By Jill Wechsler, Washington Correspondent.
The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help [...]
Posted in Guest Blog, Op-Ed, Regulatory, Safety, healthcare Also tagged drug safety, FDA, OxyContin Leave a comment
Packaging: Regulators Call for Better Patient Information
By Jacob Presson, Research Analyst at Cutting Edge Information.
Regulations concerning the contents of patient package inserts (known in the EU as “patient information leaflets” or PILs) have in the past erred on the side of caution, making sure that all of the necessary information about side effects and cross-prescription conflicts was included. Pharmaceutical companies have [...]
Posted in Europe, Global, Guest Blog, Regulatory, Strategy, healthcare, patient education Also tagged MHRA, OIG, packaging, patient information, PIL Leave a comment
US v. Caronia: What Constitutes 'Truthful' Speech?
If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?
Posted in Advertising, FDA, Legal, Marketing, Regulatory, Safety, Sales, Strategy, compliance Also tagged Alfred Caronia, Appeals Court, Detailing, DoJ, FDA, Federal Trade Commission, FTC, Jazz Pharmaceuticals, Marketing, off-label, Office of Prescription Drug Promotion, Orphan Medical, OTC, Professional Marketing, Promotion, sales rep, Sorrell v. IMS Health, US v. Caronia 1 Comment
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