Clinical Trials Cosmetics FDA Approval Regulation 
XTalks
JANUARY 25, 2023
Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.
Camargo
DECEMBER 13, 2021
Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Premarket Approval (PMA) process (CBER).
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FDA Law Blog
MAY 3, 2021
On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §
FDA Law Blog
MAY 3, 2021
Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a).
FDA Law Blog
AUGUST 16, 2021
A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.
The Pharma Data
DECEMBER 18, 2020
. “Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” said Peter Marks , M.D.,
FDA Law Blog
FEBRUARY 29, 2024
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. That did not happen.
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