Quality/GMPs

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab).

US and European regulatory officials continue to anticipate supply shortages in multiple areas.

FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.

The agency is taking steps to monitor the supply chain and assist in the development of treatments.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.

The report details OPQ’s accomplishments over the past five years.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioprocessing.

The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.

Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

Increased reliance on foreign producers raises concerns and spurs collaborations.

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.