FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.
By Michael McCaughan
In January 2010, every single original new drug application cleared by the Food & Drug Administration included a Risk Evaluation...
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The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.
Ireland’s current voluntary system for disclosing pharmaceutical company payments to health care professionals and organizations is flawed and does not adequately deal with conflicts of interests, according to an Irish law maker.
Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.
