May 13, 2020

FDA-ASCO PUBLIC WORKSHOP: 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop – 07/17/2020 – 07/17/2020

On This Page Date: July 17, 2020 Time: 9:00 AM – 4:00 PM ET Twitter: #OCEOutcomes20  Co-Sponsor: American Society of Clinical Oncology (ASCO) Co-Chairs: U.S. Food […]
May 13, 2020

Office of Infectious Diseases Research Activities

Antimicrobial Regulatory Science Research Antibacterial drug resistance is a major threat to public health.  In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]
May 13, 2020

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference – 06/04/2020 – 06/05/2020

Meeting Overview The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on […]
May 13, 2020

FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution, While Preserving Access

Image By: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research Compounded drugs can serve an important role for patients whose medical needs cannot be […]
May 13, 2020

Compounding Quality Center of Excellence: Virtual, Interactive Training Programs

The Compounding Quality Center of Excellence’s virtual, interactive training programs with live instruction target outsourcing facility staff and offer continuing education credits. Training will open for […]
May 13, 2020

Compounding Quality Center of Excellence: Self-Guided Online Training Courses

The Compounding Quality Center of Excellence offers free, self-guided online training courses on quality manufacturing practice requirements and compounding policies pertaining to outsourcing facilities. These courses […]
May 13, 2020

Compounding Quality Center of Excellence

FDA’s Compounding Quality Center of Excellence is focused on improving the quality of compounded drugs, primarily those made at outsourcing facilities. Compounded drugs pose unique risks […]
May 13, 2020

Fact or Fiction: What to Know About Smoking Cessation and Medications

[embedded content] Spanish Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent […]
May 12, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 12, 2020

For Immediate Release: May 12, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
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