/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2026-02-10-22-35-41-278-698bb2bdf64f040beedf144a.jpg)
The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2026-02-05-21-16-34-432-698508b2d97369bdf1cc4027.jpg)
On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2026-02-03-16-57-40-667-698229041d702b3a6167dad7.jpg)
Congress Probes Chinese Biotech GLP-1 Product Compliance Although the FDA recently implemented additional safeguards related to imported...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2026-02-02-21-29-34-270-6981173e1a718361944c6b35.jpg)
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2025-10-07-00-19-57-956-68e45cada769203914751a4f.jpg)
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs)...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2025-08-10-03-38-27-707-68981433242c16c74fd08785.jpg)
On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug...
/Passle/5fb3c068e5416a1144288bf8/SearchServiceImages/2025-06-27-18-26-59-771-685ee27356695e284e08d6aa.jpg)
On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American...
As of April 6, 2021, there are 355 different tests available. Each of these tests have their own regulatory requirements and their own...