Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

MAY 13, 2021

In a major double-blind clinical trial published in the American College of Endocrinology…. Which has been proven in numerous clinical trials to: Rhodiola is a flowering plant that grows in the remote regions of the Arctic… And in a major randomized, double-blind, and placebo-controlled study published in the Journal Planta Medica….

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Agency IQ

JULY 28, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. But despite the law’s age, it is not yet fully operational. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Drug & Device Law

NOVEMBER 1, 2022

This is the causation variant that we described here as “ not quite physician failure to read ,” since the pertinent testimony was in the nature of a failure to remember reading the relevant information rather than an absolute “never read it” from the implanter. Testimony that the fall was a potential cause ? the defendants won 12½.

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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