Regulatory Authority Actions

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

Industry should be seeking more information from FDA on how it will restart its current inspection program.

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

483s and Warning Letters Point to Inadequate Quality Oversight

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

FDA can better monitor quality production of domestic versus foreign firms.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.

Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.

The agency will be waiving fees for scientific advice for academia developing orphan drugs.

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.