Regulatory Oversight

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.

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The European Medicines Agency has issued a vacancy notice for the position of executive director.

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

Empty and prefilled syringes must pass a range of quality control tests.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States

EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.

The new guidance document discusses reproductive toxicity testing and labeling recommendations.

Managing and controlling e-records is vital for maintaining CGMP data integrity.

New agency leadership is pressed to promote innovation while addressing safety and quality issues.