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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
With Pataday Extra Strength, Alcon Eyes Consumers Looking For OTC 24-Hour Eye Allergy Remedy
Pataday Once Daily Relief Extra Strength is the same formulation as Novartis' Rx Pazeo. It will be the first OTC eye drop indicated for allergy itch with 24-hour efficacy, available online in September and through retailers in early 2021.
US FDA Restarting Domestic Inspections, Prioritizing Areas With Low Covid-19 Rates
The agency is resuming domestic inspections using a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.
US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight
Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.
Legislation
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Latest From Health & Legislation
US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight
Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.
Expanding US FDA Mandatory Recall Authority To All Drugs Gets House Appropriators’ Approval
Appropriators’ FDA FY 2021 budget includes amendment to expand its mandatory recall authority introduced by chairman of subcommittee with oversight of agency’s budget, Rep. Sanford Bishop. He said the agency should be able to force drug product recalls as it already can for vaccines, medical devices and products containing ingredients also scheduled as controlled substances.
US House Appropriators Keep A Bullseye On FDA’s CBD Regulation Development
Appropriations subcommittee notes the funding in summary of its draft budget bill. Language on FDA’s development of CBD regulatory framework will be included in panel’s report to be released 24 hours before full committee’s markup.
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