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

Alta Sciences

JULY 25, 2024

39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I An increasing number of advanced methods for dermal drug delivery can contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. Watch the webinar. Watch the webinar. The Altascientist: Issue No.

Science 52

Science Clinical Trials Clinical Pharmacology FDA 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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FDA Science Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

On March 26, the Supreme Court will hear the case of Alliance for Hippocratic Medicine vs. FDA , a case which calls into question FDA’s authority to make regulatory changes, to be free from unreasonable scrutiny, and to ensure that the abortion drug mifepristone remains both approved and widely available.

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FDA Science Clinical Trials Regulations 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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