Regulatory Authority Actions

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

The agency is postponing the inspection of most foreign facilities through April 2020.

The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.

Emergency actions to protect patients and the drug supply may have long-term implications.

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

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.

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FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.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

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.

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 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.