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FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.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

per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. In the pharmaceutical segment, Gelteq advances its lead product — a gel-based pain management therapy — through the US Food and Drug Administration (FDA)’s 505(b)(2) pathway.

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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

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

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Clinical Trials Clinical Trials Trials Containment 40