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Regulation/Legislation (Health)
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Warnings Up As FDA Trims Its List Of Uninspected OTC Drug Manufacturers
Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety and Innovation Act of 2012 pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and January 2018, 25% received "official action indicated" inspection results, prompting warning letters and import alerts.
Swiss Regulatory Change Takes Over 500 OTCs Out Of Pharmacy
France’s AFIPA Hits Back After Health Minister Takes Swipe At Self-Medication
French OTC industry association unhappy with health minister’s suggestion that certain non-reimbursed medicines are “useless”.
Regulation
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Latest From Health & Regulation
Dietary Supplement Firms' Sun Protection Claims Scorched In NAD Review
National Advertising Division advises firms marketing supplements with claims to protect skin from sun rays to discontinue statements similar to claims made by four supplement firms FDA warned in May. Novahue and Dermatology Industry both disagreed with NAD but would comply with its recommendations.
TummyZen Firm Appeals After Heartburn Claims Don't Settle Well In NAD Review
Eli Consumer Healthcare is latest supplement marketer National Advertising Division has advised that tests of separate ingredients do not support claims for a whole product. Following NADs review of TummyZen claims on challenge by Tums firm GlaxoSmithKline, Eli Consumer appeals NAD's recommendations to discontinue claims that its supplement “stops acid production,” is “acid inhibiting,” “halts the secretion of chloride ions in your parietal cells to regulate the release of acid into your stomach,” “supports stomach lining” and is “long lasting."
French Public Throw Support Behind Homoeopathic Reimbursement
Homeopathy continues to come under the spotlight in Europe, with France the latest country to examine the value of reimbursing such products.
Legislation
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Latest From Health & Legislation
'Lame Duck' Congress Has High Stakes For Pharma Companies
Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US FDA Office of New Drugs.
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