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zbw2 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
Its not just Dietary supplements that the FDA needs more regulation on. some prescription drugs get to market unapproved. when the FDA finally gets around to getting these drugs off the market, the companies are given a long period of time to stop making and distributing them. “FDA officials expect companies that have listed products with the agency (Physicians desk reference) to stop making them within 90 days, and to stop shipping them within 180 days.” they are given far too much time for some drugs that have “potentially life-threatening side effects”. and because some companies don’t update the FDA with all the drugs they make, the FDA is unaware that some drugs even exist on the market.
https://consumer.healthday.com/respiratory-and-allergy-information-2/misc-allergy-news-17/fda-bans-unapproved-prescription-cough-cold-and-allergy-meds-650504.html
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm