Oversight and Investigations Subcommittee conducts hearing as subcommittee chair Morgan Griffith and Energy and Commerce chair Cathy McMorris Rodgers leave no doubt they give FDA failing grade on foreign inspections. Five foreign facilities among firms in FDA’s latest warnings.
The Food and Drug Administration posted its latest warning letters including multiple ex-US OTC drug firms found in violation of manufacturing regulations as House Republicans criticized its foreign facility inspection work.
The Energy and Commerce Committee’s Oversight and Investigations Subcommittee on 6 February conducted a hearing as subcommittee chair Morgan Griffith, R-VA, and full committee chair Cathy McMorris Rodgers, R-WA,
“I’m concerned that the FDA is failing in its mission
HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.
A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.
Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.
“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.
AESGP, MedTech Europe and other associations representing medtech companies including manufacturers of self-care devices call for such products to be included in European Commission proposals for “zero-for-zero” trade in industrial goods between Europe and the US.
The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.
An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.
