The FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement.Read More
CDRH recently released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act.Read More
The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.Read More
The FDA has warned GRI Medical & Electronic Technology for corrective and preventive action (CAPA) shortfalls and its handling of nonconforming product.Read More
Companies drafting a social media policy in anticipation of upcoming FDA guidance should try to follow the same general guidelines used for traditional marketing materials, experts advise.Read More
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
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 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
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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