pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.

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pharmaphorum

OCTOBER 4, 2022

Part 2 of this series is devoted to clinical decision support (CDS) software. Criteria for regulation. 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). Criterion 1. Criterion 2.

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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.

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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

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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

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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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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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