Titles
- Reductions in deaths and hospitalizations associated with COVID-19 vaccinations among Medicare beneficiaries: full year 2021 estimates2
- Referencing approved drug products in ANDA submissions2
- Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff2
- Risk evaluation and mitigation strategies: modifications and revisions2
- Submission of plans for cigarette packages and cigarette advertisements (revised)2
- Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)2
- Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)2
- The Siamese twins2
- Understanding coverage considerations for COVID-19 vaccines and treatments2
- "I swear by Apollo physician--": Greek medicine from the gods to Galen1
- 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff1
- 340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters1
- 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations1
- A Bauluk1
- A Conversation Remembering Michael E. DeBakey with Dr. Donald A. B. Lindberg and Dr. Denton A. Cooley1
- A Conversation Remembering Michael E. DeBakey with Dr. Donald A. B. Lindberg and Katrin DeBakey1
- A Moment of Opportunity: Keynote Address to the First Meeting of the Society of Handicapped Physicians, Washington, DC [Reminiscence]1
- A Path to Discovery: The Career of Maclyn McCarty1
- A Really Terrific Sermon [Reminiscence]1
- A Time and a Place for Wisdom: Keynote Address to the Surgeon General's Workshop on Solid Organ Procurement for Transplantation, Winchester, Virginia [Reminiscence]1