FDA Law Blog

JULY 23, 2024

FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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Drug Delivery Drugs Bioequivalency Production 105

XTalks

NOVEMBER 6, 2024

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements. Priced at $4.0

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Drug Delivery Drugs Bioequivalency Bioavailability 104

pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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Bioequivalency Drugs Production Manufacturing 52

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. About TLC.

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Clinical Trials Clinical Trials Trials Containment 40