Categories
- All
- Animal & Veterinary
- Award
- Biologics
- Coronavirus
- Cosmetics
- Design
- Dietary Supplements
- Drugs
- Follow @FDAmedia on Twitter
- Follow @FDAMedia on X
- Follow @US_FDA on Twitter
- Follow @US_FDA on X
- Follow FDA on Facebook
- Food & Beverages
- Healthy
- Hotel
- Infant Formula & Foods
- Infectious Disease
- Lifestyle
- Medical Devices
- Nature
- Office
- Over-the-Counter Drugs
- Tobacco
- Training
- Travel Tips
- Travel Tips
- Vaccines
Filter Articles
Search by title or filter by category
911 articles found
-
FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter UseAgency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Ce... -
How should I represent whether a physical exam was performed in SDTM?The CDASHIG section "PE - Physical Examination" describes a best practice for collecting physical examination data. Basically, any abnormalities would be recorded as medical history or adverse events,...
-
Study Subject Site Transfers ExampleThis article provides a good example for documenting study subject site transfers, using existing SDTMIG domains and minimal supplemental qualifiers. Originally modeled for COVID studies, this approac...
-
Subject Visits and COVID-19When the Guidance for Ongoing Studies Disrupted by COVID-19 was being developed, one of the issues was how to represent subject visits, given that regulators wanted to know about visits that were mi...
-
FDA Infant Formula Update: November 2, 2022Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s increased flexibilit...
-
FDA Roundup: November 1, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a proposed rule to amend the color additive regulations to incr...
-
FDA Roundup: October 28, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA updated the list of Breakthrough Devices that have been authorized fo...
-
FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health StandardToday, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The currently market...
-
FDA Roundup: October 25, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a Safety Communications warning consumers, caregivers and hea...
-
FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette ManufacturersToday, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufactu...