Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. png Listing Introduction Clinical pharmacology information comprises more than 50% of a drug label.

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Clinical Pharmacology Drug Development Regulations FDA 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

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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. million (IQR: $18-36.7

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Science Biosimilars FDA Production 40

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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