Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation? At the same time, we have to find and implement actions that improve the significant variance in accessing new medicines across Europe.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” What happens when a drug is not stored in its original container or within a licensed facility?

Science 40

Science FDA Packaging Production 40

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA 40

FDA Science Regulations Production 40

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Preemption.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JANUARY 4, 2024

2022) (same result as to other COVID-19 vaccine). Alabama State Board of Pharmacy , 61 F.4th April 13, 2022) (available here ). 2022) (quoting this publication). “The Okuley’s Pharmacy & Home Medical , N.E.3d 247d-6d(b)(8). 25, 2023); Goins v. Saint Elizabeth Medical Center , 640 F. 3d 745, 753 (E.D.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59