As CDRH focuses on coronavirus-related activities, the Center extends its reliance on teleconferences in lieu of in-person meetings with industry.
FDA posts a final guidance entitled Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Covid-19) Public Health...
FDA posts a final guidance on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.
FDA Review posts product approval summaries for the week ending 4/3/2020.
Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice in Manufacturing, Packaging,...
FDA posts a 3/5 FDA 483 citing a Dr. Reddys Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) facility last month.
Federal Register notice: FDA sends to OMB an information collection extension for Certification of Identity; Form FDA 3975.