Human Drugs
Individualized Antisense Oligonucleotide IND Guidance
FDA issues a draft guidance to help sponsors develop individualized antisense oligonucleotide drug products.
Federal Register
Federal Register Notices: Week Ending 1/1/2021
Federal Register notices published the week ending 1/01/2021 while we were on our annual holiday break.
Federal Register
Federal Register Notices: Week Ending 12/25/2020
Federal Register notices published the week ending 12/25/2020 while we were on our annual holiday break.
FDA General
Latest FDA Warning Letters
FDA Webview posts the latest Warning Letters that were released the weeks ending 12/25/2020 and 1/1/2021 while we were on our annual holiday break and...
Human Drugs
FDA Tallies 53 Novel Drug Approvals in 2020
FDA approves 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 despite challenges from balancing resources to navig...
Human Drugs
2 Observations in OSO Biopharmaceuticals FDA-483
FDA releases the FDA-483 with two observations issued following an inspection at OSO Biopharmaceuticals Manufacturing.
Medical Devices
Legacy Pharmaceutical Packaging FDA-483
FDA releases the FDA-483 with five observations from an inspection at Legacy Pharmaceutical Packaging, a medical device contract manufacturer.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Info Collection on FDA Fellowship Applications
Federal Register notice: FDA sends to OMB an information collection extension for Application for Participation in FDA Fellowship and Traineeship Prog...
Federal Register
FDA Proposes Human Tissue Regulations Revocation
Federal Register notice: FDA proposes to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to ...
