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Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures | JD Supra
JD Supra· 22 hours agoBased on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov.
Fact Check: Ground Crickets Are Supposedly Added to Foods Under the Name 'Acheta Powder.' Here's...
Snopes via Yahoo News· 6 days agoAccessed 26 Apr. 2024. Nutrition, Center for Food Safety and Applied. "Generally Recognized as Safe...
FDA Issues Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 7 days agoOn April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro...
Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC...
FOX40 Sacramento· 19 hours agoFood and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart etedesiran (AOC 1001), the company's lead clinical development program, for ...
Mitsubishi Tanabe Pharma America to Present RADICAVA ORS® (edaravone) Real-World Data at the...
WROC Rochester· 5 days agoMitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of an abstract in amyotrophic lateral sclerosis (ALS) at the Professional Society for Health Economics and Outcomes ...
JD Supra: Non-Lab Diagnostics: FDA Regulatory Considerations
JD Supra· 4 days agoCompanies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations.
Love Is Like Oxygen (Unless FDA Thinks You Get Too Much, You Get Too High): FDA Issues a Warning...
JD Supra· 6 days agoOne of the catchiest songs written by the 1970s British glam rock band, Sweet, is “Love Is Like Oxygen,” released in 1978. The chorus includes the lyrics, “Love is like oxygen; you get too much ...
JD Supra: Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device...
JD Supra· 6 days agoThis Bulletin summarizes the issues involved and our observations. FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations ...
Separate E.Coli recalls affect Louisiana residents. Here’s what you need to know
Shreveport Times | The Times via Yahoo News· 6 days agoTo see the full list of stores who may have received these walnuts, visit www.fda.gov. Ground Beef...
Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted...
Fairfield-Suisun Daily Republic· 2 days agoFood and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC") will review data supporting the new drug application ("NDA") for midomafetamine ...