FDA News

FDA Warns Chinese Devicemaker, Citing Lack of CAPA Triggers

The FDA has warned GRI Medical & Electronic Technology for corrective and preventive action (CAPA) shortfalls and its handling of nonconforming product.Read More

Experts: Use Traditional Marketing as a Guide for Social Media Policy

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

Novartis Gets 483 for Batch Quality Control Process Flaws

The method Novartis uses to clear batches at its Suffern, N.Y., facility was deemed inadequate by FDA investigators, resulting in a Form 483.Read More

Gamechanger: FDA Tests Counterfeit Detection Device

The FDA plans to test a device in Ghana in 2013 and 2014 that it hopes will root out counterfeit and substandard antimalarial drugs. Read More

FDA Finds Complaint Handling Mistakes at Mattress Maker

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

Report on EU IVD Regulation Calls for Stricter Controls Over Clinical Trials, Genetic Testing

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

Speech Therapy Devicemakers Warned Over Quality System Shortfalls

The FDA has warned two makers of speech therapy devices for quality system issues, as well as for lacking device approvals or clearances.Read More

FDA Approves OTC Plan B Drug But Not in Response to Court Order

The FDA late Tuesday approved Teva’s Plan B One-Step contraception for women 15 years and older for over-the-counter use.Read More

Brazil Moves on 2009 Drug Tracking Law; Eyes Streamlined Inspections, Registration

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

Warning: Inspection Response Lacks ‘Holistic’ Action Plan for Defects

An FDA warning letter to CORPAK MedSystems calls out the company’s handling of defective stylets and complaints related to their use.Read More

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Resource Center

Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
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
Conducting Bulletproof CAPA Investigations — ADVANCED
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause
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
Surviving an FDA Inspection
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! Read More