Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

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The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the change in RoA required a single-species, one-month good laboratory practice (GLP) toxicology study. This nonclinical study required good manufacturing practice (GMP) drug product, sham product, and vehicle to qualify the novel excipient used to modify absorption.

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Drug Discovery World

AUGUST 15, 2023

Unexpected late-stage failures in drug development are, of course, the costliest. However, many other drugs exhibit a more complex multichannel pharmacology 7 , which is much harder to interpret and cannot be easily modelled by screening against a single ion channel. Clinical Pharmacology & Therapeutics.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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FDA Science Biosimilars Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

DECEMBER 1, 2023

The FDA has said in court filings that it plans to make a decision about Florida’s prescription drug importation proposal in December, and recently pushed back a response date related to a similar plan from Colorado. Whatever the agency decides could result in new lawsuits or negative political attention.

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