Regulatory Affairs News Channel

FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA's thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases

The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies.

FDA takes additional actions on the use of a booster dose for COVID-19 vaccines

Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:

FDA awards 11 grants to clinical trials to develop new medical products for rare disease treatments

Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over the next four years. The FDA's Congressionally-funded Orphan Products Grants Program awards these grants to clinical investigators to support the development of medical products for patients with rare diseases.

FDA approves innovative treatment for pediatric patients with congenital athymia

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S.

"Today's action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

FDA authorizes software that can help identify prostate cancer

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body).

FDA advances data, IT modernization efforts with new office of digital transformation

Today, the U.S. Food and Drug Administration announced the reorganization of the agency's information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level.

Regulatory Affairs News

FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age

FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases

FDA takes additional actions on the use of a booster dose for COVID-19 vaccines

FDA awards 11 grants to clinical trials to develop new medical products for rare disease treatments

FDA approves innovative treatment for pediatric patients with congenital athymia

FDA authorizes software that can help identify prostate cancer

FDA advances data, IT modernization efforts with new office of digital transformation

More Pharma News ...

Business & Industry

Research & Development

Conferences & Events

Regulatory Affairs