Regulatory Oversight

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

CHMP has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

CMA has issued a statement of objections provisionally finding that four pharmaceutical companies have broken competition law.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

SenzaGen has revealed that is has been granted a patent in Europe for GARDpotency, a testing application that enables the measurement of the allergenicity of chemical substances without animal research.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has issued a drug alert concerning a class 2 medicines recall of paracetamol tablets.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

FDA’s annual manufacturing report card shows more quality compliance is needed.

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.

Discussing supply chain risk and security as a business led journey, Roddy Martin, chief digital strategist at TraceLink, explains the five stages of its evolution.

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.