Clinical Trials Cosmetics In-Vitro 
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).
pharmaphorum
SEPTEMBER 29, 2022
Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA has opined on several categories of mHealth: general wellness devices, mobile medical applications (MMAs), and clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. not a medical device, ii.
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pharmaphorum
OCTOBER 4, 2022
Part 2 of this series is devoted to clinical decision support (CDS) software. 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.
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
DECEMBER 20, 2022
Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. NEW YORK, December 20, 2022 -- Pfizer Inc. In the U.S., approximately 7.6
Pfizer
NOVEMBER 23, 2022
Clinical data and real-world evidence for PAXLOVID have shown that it can be an important tool in helping to reduce hospitalizations and deaths in those at increased risk of serious illness from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As This agreement will supply participating countries up to 3.4
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. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.
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