Vaccine Development – 101
COVID-19 Update: FDA Authorizes First COVID-19 and Flu Combination Test
COVID-19 Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

COVID-19 Update: FDA Authorizes Monoclonal Antibodies for  COVID-19 Treatment

COVID-19 Update: FDA Authorizes Drug Combination for COVID-19 Treatment

Insight: Personal Protective Equipment and COVID-19
Update: Agency’s Ongoing Commitment to Transparency for COVID-19 EUAs
A Closer Look at COVID-19 Diagnostic Testing
Update: Monoclonal Antibody for Treatment of COVID-19 Authorized
COVID-19 Update: Agency Issues EUA for First COVID-19 Test for Self-Testing at Home

Remarks for the Global Pharmaceutical Manufacturing Leadership Forum

Agency’s Vaccines/Related Biological Products Advisory Committee’s Role in Advising Agency on COVID-19 Vaccines
Insight: Get Your Flu Shot
First Treatment for COVID-19 Approved
PAST: Vaccines/Related Biological Products Advisory Committee October 22, 2020 Meeting

FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines

FDA Reissues EUA for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
Virtual Town Hall Series - COVID-19 Test Development and Validation 10.28.20
The Review Process for Vaccines to Prevent COVID-19: A Discussion

In Brief: Guidance on EUA for COVID-19 Vaccines Issued

Closer Look at Agency’s Center for Devices and Radiological Health’s Unprecedented Efforts in COVID-19 Response

FDA Authorizes First Point-of-Care Antibody Test for COVID-19
COVID-19: An Update on the Federal Response 
Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests (9.30.20)
Agency’s Scientific and Regulatory Oversight of Vaccines Vital to Public Health
Agency and Global Partners to Analyze Coronavirus Samples
[Slides] Gowns, Other Apparel for Use by Health Care Personnel in COVID-19 Pandemic
Update: Published Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

Advancing Science of Real-World Data to Address COVID-19 Pandemic
Insight: The Opioid Epidemic and COVID-19 Pandemic

Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
Update: FDA Broadens EUA for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19
Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food/Drink Containers
Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card

Coronavirus Treatment Acceleration Program (CTAP)
Insight: Drug Shortages and COVID-19 (audio)
Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
EUA Issued for Convalescent Plasma as Potential Promising COVID-19 Treatment
Insight: Health Fraud and COVID-19

Agency Issues EUA to Yale School of Public Health for Saliva Direct, Uses New Method of Saliva Sample Processing
COVID-19 Daily Update 8.17.2020
The Critical Role of Health Care Professionals During the COVID-19 Pandemic (speech)

COVID-19 Daily Roundup August 12, 2020
Fraudulent COVID-19 Products
FAQs on the Emergency Use Authorization for Remdesivir for Certain Hospitalized COVID-19 Patients
COVID-19 Update: Daily Roundup 8.5.20
COVID-19 Update: First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection Authorized

Investing in Advanced Manufacturing to Support Public Health Preparedness

Webinar: FDA’s Regulation of Face Masks/Surgical Masks During COVID-19 Pandemic
Updates on Hand Sanitizers Consumers Shouldn’t Use

Update: New Template for At-Home/Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools, Posted
Insight: Vaccines for COVID-19, Part 2
Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action . . .
Update: Daily Roundup July 27, 2020
Update: First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection Authorized
Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19 . . .

FDA’s Ongoing Work to Support/Advance COVID-19 Diagnostic Test Accuracy/Availability
Insight: Vaccines for COVID-19, Part 1
Update: First Emergency Authorization for Sample Pooling in Diagnostic Testing Authorized
Webinar: Respirators for Health Care Personnel Use During the COVID-19 Pandemic
Update: FDA’s Coronavirus Treatment Acceleration Program
Insight: Clinical Trials and Treatments for COVID-19

Updates on Hand Sanitizers with Methanol
COVID-19: Educational Resources

Donate COVID-19 Plasma
FDA: Issued Emergency Use Authorization for Point of Care Antigen Test
FDA: Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season
FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
Insight: All About COVID-19 Testing

Update: Action Taken to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
Partnering with European Union and Global Regulators on COVID-19
Insight: Fighting COVID-19 at the FDA
Daily Roundup COVID-19 6.24.20
Agency Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
Webinar - Respirators for Health Care Personnel Use during COVID-19
Facilitating Diagnostic Test Availability—Asymptomatic Testing/Sample Pooling
EUA Revoked for Chembio Antibody Test
Warning Ltrs Sent to Companies Inappropriately Marketing Antibody Tests . . .
Revocation of EUA for Chloroquine and Hydroxychloroquine
Rare Disease Therapy Development/Access Top FDA Priorities During COVID-19
Resources: N95 Respirators, Surgical Masks, Face Masks
First Next Generation Sequence Test for Diagnosing COVID-19 Authorized
Daily Update: COVID-19 6.10.20
EUAs Revising Which Types of Respirators Can Be Decontaminated for Reuse Reissued
Antibody Test Performance Data From Kits as Part of Validation Study
Daily Roundup COVID-19 6.4.20

Daily Roundup COVID-19 6.3.20
Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety
COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process

Remarks by Commissioner Stephen Hahn, M.D. —COVID-19—Finding Solutions, Applying Lessons Learned
Understanding Regulatory Terminology of Potential Preventions/Treatments for COVID-19

Daily Roundup COVID-19 6.1.20
New Tool to Aid Development/Evaluation of Diagnostic Tests Detecting SARS-CoV-2
Daily Roundup COVID-19 5.28.20
Daily Roundup COVID-19 5.26.20
Promised Transparency for Antibody Tests
Daily Roundup COVID-19 5.21.20
Daily Roundup COVID-19 5.20.20
USDA, FDA Strengthen U.S. Food Supply Chain Protections
EUA for emergency use of Fresenius Propoven 2% Emulsion…ICU setting during…COVID-19 pandemic
Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
Daily Roundup COVID-19 5.18.20
Daily Roundup COVID-19 5.15.20
Daily Roundup COVID-19 5.14.20
Daily Roundup COVID-19 5.13.20

Promised Transparency for Antibody Tests
FDA Takes New Actions to Accelerate Dev of Novel Prevention, Treatment for COVID-19
FDA Authorizes First Antigen Test…Rapid Detection of Virus that Causes COVID-19
Emergency Use Authorizations-List
Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
Daily Roundup COVID-19 5.5.20
FDA Issues EUA - Potential COVID-19 Treatment
Daily Round Up COVID-19 4.24.20
Daily Roundup COVID-19 4.23.20
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside hospital setting or clinical trial …

Daily Roundup COVID-19 4.21.20
EUAs COVID-19 (devices; list)
Daily Roundup COVID-19 4.20.20
Accelerated EUA Summary COVID-19 RT-PCR Test
Update: Serological Test Validation/Education
Daily Roundup COVID-19 4.17.20

EUA to Decontaminate Millions of N95 Respirators
Enforcement Policy: Ventilators, Accessories and Other Respiratory Devices (COVID-19)

Virtual Town Hall-Guidance on (COVID-19) Diagnostic Tests 4.8.20

Latest COVID-19 Information
Updated Guidance Addresses Urgent Need for Blood During Pandemic

Statement on Use of Face Masks Brought From Home
TJC Issues Statement re PPE Shortages