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Regulation/Legislation (Health)

Set Alert for Regulation {Health}

Poland Gives Green Light To Switches From Teva and Polpharma

Teva and Polpharma's OTC operations in Poland are set to received a boost with the approval of two switches by national medicines regulator URPL. Polish consumers can now get OTC access to additional treatments for hay fever and cough. 
Prescription To Otc Switch Poland OTC Drugs

German Industry Tries To Nip Homeopathy Debate In The Bud As France Decides In Favour Of De-Reimbursement

As France decides to de-reimburse homeopathic medicines, discussions about whether this should be applied to Germany are being re-opened by politicians and high-profile representatives from the country's statutory health insurance system. Industry has responded by saying "no" to de-reimbursement, as the German system allows consumers to choose between insurers based on their views of homeopathy. 
Health OTC Drugs 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.

OTC Drugs FDA Regulation

Regulation

Set Alert for Regulation {Health}

Latest From Health & Regulation

False Documents Land Chinese OTC Firm In Real Regulatory Trouble With US FDA

As HBW Insight reported, following inspection in March, FDA placed Huize Commodity's hand sanitizers, sunscreens and lip balms on import alert in June. During FDA inspection, "multiple documents provided were in fact falsified," according to warning.
OTC Drugs Commercial

NRT Delivery Innovation Proposal In US Doesn't Deliver Expanded Indications

GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.

OTC Drugs Regulation

Health And Wellness Product Trademark Review 13 August, 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 Drugs Dietary Supplements
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

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.

OTC Drugs Dietary Supplements

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."

OTC Drugs FDA

Acetaminophen Dose Labeling, More Sunscreen Information Needed, House Appropriators Tell FDA

Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.

OTC Drugs Legislation
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