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The FDA on Thursday released final guidance on how the agency will weigh the legally required factors when considering whether to require a risk evaluation mitigation strategy for medicines. Read More
The FDA and Customs and Border Protection are teaming up to help crack down on illegal opioids flooding the country, Commissioner Scott Gottlieb announced Thursday. Read More
HHS Secretary Alex Azar on Thursday asked Senators for their support for rule changes that would redirect prescription drugs discounts toward customers. Read More
FDA Commissioner Scott Gottlieb is leaving the agency on Friday to rejoin the American Enterprise Institute—a conservative think tank—where he will work part-time on drug pricing issues. Read More
The FDA is also seeking $76 million to support drug compounding activities and develop new regulations to improve the quality of products from outsourcing facilities. Read More
FDA Commissioner Scott Gottlieb and CBER director Peter Marks on Wednesday announced enforcement efforts the agency is taking against stem cell clinics and manufacturers that put patients at risk by marketing unapproved products. Read More
The FDA’s proposed guidance on Risk Evaluation Mitigation Strategies will be much easier for brand-name drugmakers to implement than for generic manufacturers, the Association for Accessible Medicines says. Read More
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on Wednesday. Read More
When a drug can be used safely in pediatric populations, it should be made clear in the drug’s “indications and usage” section, the agency says. Read More