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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

Health And Wellness Trademark Review 3 December, 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.

Trademarks OTC Drugs

HBW Executive Decisions: HELP Endorses Hahn, Industry Award For AHPA's McGuffin, CHPA, Herbalife Hires

CHPA adds Allgaier to head development, relations; Vetere joins Herbalife as VP, CIO; Hahn's FDA commissioner nomination clears HELP committee; and AHPA's McGuffin recognized as 2019 Industry Leader.

Appointments OTC Drugs

Sore Throat Drugs Heading Behind The Counter In France Over Safety Fears

France's drugs agency wants to restrict sales of OTC sore throat treatments marketed by Sanofi and others to behind the pharmacy counter due to fears of potential adverse events.
France Drug Safety
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

OTC Monograph Reform May Have To Launch Without User Fees, Senate Sponsor Says

"We believe that we're going to get this done," but "it's possible that ... language authorizing the collection of user fees is not included in this year's appropriation legislation," says Sen. Bob Casey during HELP Committee's confirmation hearing for FDA commissioner nominee Stephen Hahn.

OTC Drugs Legislation

Children's Nicotine Addiction A Hot Seat At FDA Commissioner Nominee Hearing

Senate Health, Education, Labor and Pensions Committee members make clear their expectations in questions and comments during hearing on confirmation of FDA commissioner nominee Stephen Hahn.
OTC Drugs FDA

HBW Legislative News: Another Federal CR, Michigan On DXM List, Senators Say Supplements Are 'Medical Expenses'

Federal agencies at FY 2019 funding for another month; Michigan imposes age restriction on OTC DXM sales; and senators urge IRS to make supplements 'medical expenses'.

OTC Drugs Dietary Supplements
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