Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
FDA has selected nine major medical device and technology companies to be part of its Pre-Cert pilot program, including Apple, Fitbit, Johnson & Johnson, Samsung, Verily and Roche, agency chief Scott Gottlieb announced during the Advanced Medical Technology Association's MedTech Conference on Tuesday (Sept. 26).
FDA Commissioner Scott Gottlieb made the business case Sept. 13 that regardless of where one comes down on the debate over the true cost of drug development, the costs are too high and may chill investment in biotech and ultimately may stifle drug development.
FDA is updating its existing warnings on the dangers of combining addiction medications and certain anxiety and insomnia drugs to emphasize that despite the potential for potentially deadly interactions, medication-assisted treatment (MAT) for opioid addiction should not be withheld from patients already taking these anxiety medications.
FDA Commissioner Scott Gottlieb will testify at an Oct. 5 Senate health committee hearing on the federal response to the opioid crisis.
FDA calls for biosimilar sponsors to use a risk-based approach when choosing statistical methods to demonstrate analytical similarity to a reference product, laying out the policy in a long-awaited draft guidance released Thursday (Sept. 21).
FDA will publish guidance detailing how drug developers can use real-world evidence to satisfy FDA’s pre- and post-market requirements, agency head Scott Gottlieb said during an RWE workshop held at the National Academies of Sciences, Engineering, and Medicine on Tuesday (Sept. 19).
A new white paper by the Duke-Margolis Center for Health Policy appears to put to bed a question that has flummoxed FDA and its advisers: whether real-world evidence (RWE) can include randomization.
FDA is going against congressional intent and potentially running afoul of the law by quietly killing its earlier plans to implement portions of the Drug Quality and Security Act (DQSA), a drug industry attorney tells Inside Health Policy.
The CEO of leading compounder, Imprimis Pharmaceuticals, tells Inside Health Policy that despite allegations that it is running afoul of multiple federal laws, FDA is aware of the company's actions and almost all compounders are compounding ingredients that have not been greenlighted by FDA and face no enforcement action.
FDA will release guidance within two months green lighting certain office-use compounding, so long as those 503A pharmacies register as 503B outsourcing facilities, and in exchange these compounders will be subject to “more tailored” manufacturing standards, an agency spokesperson tells Inside Health Policy.
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