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Regulation/Legislation (Health)
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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.
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.
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
Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Guidance Opening Sanitizer Production Stirs Firms Including Anheuser-Busch, Dow, Kodak
Dow Chemical, Anheuser-Busch and Kodak designate manufacturing for hand sanitizers and donate products to fight COVID-19. Dow is making up to 15 tons of sanitizer a day while Kodak donates formulas to New York's “NYS Clean” sanitizer distribution program.
US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
Legislation
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Latest From Health & Legislation
US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
US Pandemic Relief Package Delivers OTC Industry Regulatory Wishes, Supplement Business Hopes
It’s unlikely any industry stakeholder or FDA official expected a bill providing emergency economic relief to consumers, industries and health care services and facilities in response to a pandemic, including extensive support opportunities for small businesses, would be the vehicle that delivers on both of the industry’s congressional wishes. The supplement industry also looks for help in CARES Act.
OTC Monograph Reform Emerges In Senate Proposal For Covid-19 Economic Relief
Senate pandemic economic relief legislation legislation would reform monograph drug program and allow purchases of OTC drugs with pre-tax health savings accounts. But lingering disagreements between Democrats and Republicans blocked the Senate's passage of the bill on 25 March.
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