Quality/GMPs

The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.

Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Despite the clear danger of COVID-19 to global health, vaccine opponents have gained ground, as fearful populations lose faith in the capabilities of industry and government to protect public health.

The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

FDA and the US Congress support innovation and access to cheaper medicines.

The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.

The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.

Biopharmaceutical companies and federal agencies have been working overtime and assuming considerable risk to be able to supply billions of doses of any safe and effective preventive.

The International Coalition of Medicines Regulatory Authorities held a virtual meeting of regulators from around the world to discuss policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events met on May 13, 2020 to discuss measures the European Union is taking to ensure the availability of medicines during the COVID-19 pandemic.

The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.

A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.

Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.

The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.

AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Policy makers seek to ensure supplies of new therapies and to limit shortages.