Regulatory Authority Actions

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

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.

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.

The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.

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.

A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.

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

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

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

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.

The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.

EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.

The agency has been tasked with coordinating efforts to mitigate shortages of medicines within Europe during the COVID-19 pandemic.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.