SCM True Air Technologies, a maker of therapeutic mattresses, fielded a four-observation Form 483 related to its handling of complaints and manufacturing changes.Read More
The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.Read More
Anvisa recently weighed in on the benefits of recognizing international good manufacturing practice (GMP) certificates from drugmakers seeking to register products in the country.Read More
To minimize the risk of patients developing cancer associated with the exposure to some impurities, the FDA is adopting draft international harmonization guidelines on identification and control of mutagenic impurities in drugs using genotoxic or carcinogenic starting materials.Read More
FDA Commissioner Margaret Hamburg said Tuesday that conditions at a number of recently inspected compounding pharmacies were “truly startling,” including rusty tools and facilities, employees handling drug components with bare hands and black particles floating in solutions that were supposedly sterile.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!
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