FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Disease Clinical Pharmacology Science 105

The Pharma Data

NOVEMBER 1, 2020

The Company also has secured major industry partnerships, including its collaboration with AbbVie in November 2018, for the research and preclinical development of specified DUB inhibitors for the treatment of Alzheimer’s Disease and Parkinson’s Disease.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

New Drug Approvals

SEPTEMBER 13, 2024

30 January 2018. “Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects” Journal of Clinical Pharmacology. Reed B, Butelman ER, Fry RS, Kimani R, Kreek MJ (March 2018).

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

NOVEMBER 9, 2020

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse.

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Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. This new body of data includes environmental exposure studies and clinical trials from Merck and Johnson and Johnson collected between 2011 and 2018.

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Science FDA Clinical Trials Clinical Pharmacology 40

Eye on FDA

AUGUST 4, 2021

At the same time, looking to 2018 when there were 29 meetings to consider new drugs, the number appears to be falling each year, with only 6 that occurred during the first half of 2021. Fewer meetings – more approvals. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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FDA Clinical Pharmacology FDA Approval Therapies 122

Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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