Cosmetics In-Vitro Trials 
pharmaphorum
SEPTEMBER 29, 2022
In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. When assessing mHealth technology, the FDA will determine whether an application is either: i.
pharmaphorum
OCTOBER 4, 2022
The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) were considered. Part 2 of this series is devoted to clinical decision support (CDS) software.
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FDA Law Blog
FEBRUARY 2, 2023
Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). FDORA § 3209(a)(1).
FDA Law Blog
OCTOBER 11, 2022
We use the term “confirmatory evidence” as short-hand for one of the two ways explicitly defined in the Federal Food Drug & Cosmetic Act (“FD&C Act”) for demonstrating substantial evidence of effectiveness. Some may confuse this requirement for two studies as a need for replication.
Pfizer
DECEMBER 13, 2022
Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.
Pfizer
AUGUST 15, 2022
Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement.
FDA Law Blog
OCTOBER 2, 2023
Since 1962, the Federal Food Drug & Cosmetic Act (FDC Act) has given FDA authority to reject a drug application that fails to provide substantial evidence of effectiveness. In contrast, the new September 2023 Confirmatory Evidence Guidance is dedicated solely to the single study plus confirmatory evidence pathway.
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