- Patent Certifications and Suitability Petitions
- Office of Pharmaceutical Manufacturing Assessment
- Control of Nitrosamine Impurities in Human Drugs
- Tainted Sexual Enhancement Products
- Public Notification: Alpha Male Plus contains hidden drug ingredient
- Public Notification: Adam’s Secret Extra Strength 1500 contains hidden drug ingredients
- FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)
- FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
- Information about Nitrosamine Impurities in Medications
- Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
- FDA advierte acerca del riesgo de sangrado grave en antiácidos de venta libre que contienen aspirina
- Untitled Letters 2018
- Untitled Letters 2019
- Untitled Letters 2020
- Untitled Letters 2021
- Coronavirus (COVID-19) Update: February 23, 2021
- Compounding Activities | COVID-19
- 2020 First Generic Drug Approvals
- CDER Small Business & Industry Assistance (SBIA)
- FDA Safety Report Type Flag Requirement for FAERS Submissions - 02/19/2021 - 02/19/2021
- Absara Cosmetics S.A.P.I DE C.V. - 612455 - 02/18/2021
- CooperSurgical, Inc. - 613339 - 02/12/2021
- Antimicrobial Resistance Information from FDA
- FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression
- Novel Drug Approvals for 2021
- Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency
- Recently Issued Guidance Documents
- Peripheral and Central Nervous System Drugs Advisory Committee Roster