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Poland Gives Green Light To Switches From Teva and Polpharma
German Industry Tries To Nip Homeopathy Debate In The Bud As France Decides In Favour Of De-Reimbursement
US FDA Regulatory Roundup: Ecometrics GMP Warning, Altaire Ophthalmic Recalls
Contract manufacturer Ecometics may have distributed adulterated OTC drugs due to inadequate removal of residues from manufacturing equipment it also uses to make insect repellent, FDA says; and Altaire Pharmaceuticals expands its recall of OTC and Rx ophthalmic products due to a lack of sterility assurance.
Regulation
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Latest From Health & Regulation
Dutch Firms Not Updating Product Info Fast Enough Following Safety Alerts
Health And Wellness Products Trademark Review 15 October, 2019
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
OTC Zantac Recall: Sanofi Heeds To Potential Ranitidine Contaminant
Firm opts for recall "as a precautionary measure due to inconsistencies in preliminary test results of the active ingredient used in the US and Canadian products." Other firms marketing ranitidine in US have started recalls due to concerns about NDMA since potential problem became known in September.
Legislation
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Latest From Health & Legislation
India Poised To Create OTC Drug Category In Historic Move
Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access
Energy and Commerce members try again on monograph; Democrats want to ensure OTC oral contraceptive access; Wyden asks for faster CBD rulemaking at FDA; and House passes FDA's FY 2020 funding.
Need Private Meeting For Sunscreen MUsT Details? Just Ask, FDA Says
"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."
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