Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

Agency IQ

SEPTEMBER 15, 2023

Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

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. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The rule, will also, if finalized, address communication with State boards of pharmacy. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November.

FDA 40

FDA Science Regulations Production 40