The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature. Human factors.

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Alta Sciences

AUGUST 28, 2023

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study.

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Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. Since its inception, OCE has initiated an extensive list of initiatives and has taken the lead on over forty guidances published by FDA.

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. For now, we haven’t included all documents previously released by the FDA in draft form unless specifically included on the agency’s draft agendas. New on CDRH’s guidance agenda. Priority A List.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as the FDA’s “guidance agenda.”

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on April 28, 2011 and by the European Commission on September 7, 2011. FDA on February 8, 2018. [vi] 2 ERLEADA ® received U.S. ERLEADA ® is taken orally, once daily, with or without food.

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