FDA, peanut butter and recall
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The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.
The agency is telling consumers to throw away Rosabella moringa powder capsules with expiration dates from March to November 2027
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the agency's leaders said.
Moderna is breathing a sigh of relief now that the Food and Drug Administration said on Wednesday that it will review the company’s application for a new flu vaccine — a dramatic reversal from the agency’s refusal to do so just a week ago. But for the rest of the pharmaceutical industry, the damage might already be done.
Makary pointed to three bottlenecks: hospital contracting, ethical reviews and approvals and the Investigational New Drug applications process
Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device compliance.
Woodland Foods issued a recall for its Gourmet Arrowroot Flour on January 16 due to possible foreign material contamination.
Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.