FDA issues a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient m...
HHS withdraws a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests.
CBER sends NYC Regenerative Medicine an untitled letter over its Web site and Facebook page that markets its cellular product derived from human umbil...
FDA posts a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.
FDA Review posts product approval summaries for the week ending 11/12/2021.
The Biden Administration chooses former FDA head Robert Califf as its FDA commissioner nominee.
Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blindness causing conditi...