Regulatory Authority Actions

FDA's treatment of whistleblowers lacks internal consistency.

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, Nebraska, facility of Novartis Consumer Health, where the product is made.

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

On Feb. 21, 2011, FDA posted a copy of a Warning Letter that was sent to the chairman of the executive board of Merck KGaA on Dec. 15, 2011, regarding cGMP violations identified at three of its European facilities: MS-Corsier-sur-Vevey, MS-Aubonne, and MS-Tiburtina.

FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.

The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.

After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

The European Union market takes steps toward continuous processing and modular facilities.

EMA Hosts Subgroup Analysis Workshop.

EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.

In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive.

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.

FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

FDA Issues Final Guidance Regarding cGMPs for PET Drugs.

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use.

FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.

FDA Publishes Final Guidance on Dissolution Testing.

The Association of the British Pharmaceutical Industry (ABPI) has published a guidance that suggests best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools.

An FDA guidance has provided information for products that involve the application of nanotechnology, and rationales for those points.