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President Trump announced on Friday that he may issue an executive order to mandate a “favored nations” approach whereby the U.S. will pay no more than the lowest nation’s price for drugs. Read More
The FDA released final guidance on compounding of oral oxitriptan drugs for patients with tetrahydrobiopterin (BH4) deficiency — a rare condition caused by gene mutations — saying the agency doesn’t intend to take regulatory action against pharmacists or physicians using the bulk drug to compound oral drugs for those patients. Read More
Specialty pharmaceutical company US WorldMeds has asked the FDA to require that generic competitors for its treatment for advanced Parkinson’s disease get approval for both the medication and the medical device components of the injectable. Read More
CDER officials say they want to hear from drug companies about their concerns, and what it would take to improve the program enough to get more volunteers. Read More
Sen. Elizabeth Warren (D-Mass.) called on former FDA Commissioner Scott Gottlieb to resign from his new seat on Pfizer’s board of directors — and claimed the “revolving door influence-peddling smacks of corruption.” Read More
CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation at the Drug Information Association’s annual meeting in San Diego last week. Read More