Regulatory Oversight and Compliance

The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.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 agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

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.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.