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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 11 February, 2020

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 Dietary Supplements

CBD Lotion Firm’s ‘FDA Certified’ Claim For 'OTC Drug' Is Certifiably Noncompliant

In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.

Dietary Supplements OTC Drugs

Daring To Be 'Different' Lands Infirst In Hot Water

ASA tells Infirst that use of the word "different" in marketing implies its Flarin analgesic is more effective than other ibuprofen OTC drugs sold in the UK.
Ad Complaints OTC Drugs
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

CBD Lotion Firm’s ‘FDA Certified’ Claim For 'OTC Drug' Is Certifiably Noncompliant

In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.

Dietary Supplements OTC Drugs

FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’

In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.

OTC Drugs Legislation

More GMP Warnings, Import Alerts For OTC Firms As US FDA Capped List Of Uninspected Facilities

Most of the foreign OTC drug firms targeted in latest warnings FDA published, including the GUM oral care brand manufacturer, were placed on import alert due to GMP violations. Each was inspected by FDA during June, July or May 2019, when the agency was wrapping up an initiative to inspect all previously uninspected drug manufacturers.

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