Regulatory Authority Actions

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.

The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.

The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.

The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.

The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.

The agency has added a COVID-19 innovation resource page and an education resources page to its website.

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.

The protocol on Northern Ireland (NI) once Brexit has been completed has received mixed opinions in industry, according to various press releases.

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.