Regulatory Oversight and Compliance

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

EMA and MHRA provide insight into increased GMP deficiencies.

A Q&A with FDA Deputy Commissioner Deborah Autor.

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.

New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.

The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.

How niche strategies can offer mainstream potential for biopharmaceutical companies.

Poland's government aims to make the Eastern European country a biotech powerhouse.

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

The management board of the European Medicines Agency has introduced a range of new measures to strengthen and extend its conflicts of interest policy for scientific-committee members and experts, as well as for members of the management board.

Soaring opioid use creates challenges for new drug development and supply-chain control.

The contract provider needs to know as much as the NDA holder.

On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

Social media use raises questions about applying old standards to new information technology.

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.