Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. level, including the development of lists of critical medicines during major events that affect public health.

Regulations 40

Regulations Packaging Production FDA 40

Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). These therapies offer improved safety and high potency with fewer side effects than traditional treatments.

Trials 52

Trials Clinical Trials Therapies Regulations 52

FDA Law Blog: Drug Discovery

APRIL 23, 2023

An “externally controlled trial” is described in the Draft Guidance as a study in which “outcomes in participants receiving the test treatment according to a protocol are compared to outcomes in a group of people external to the trial who had not received the same treatment.”

Trials 49

Trials Clinical Trials FDA Treatment 49

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

SEPTEMBER 29, 2023

The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets. Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces.

Regulations 40

Regulations Government Production International 40

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations 40

Regulations Compliance Production Government 40

Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. Ther Innov Regul Sci. 2001 Sep;24(9):517–26. Regul Toxicol Pharmacol RTP. 2018;53(4):519–25.

Drugs 111

Drugs FDA Disease Animal Testing 111

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

Pharmaceuticals 40

Pharmaceuticals Packaging Regulations Production 40

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. no[r] a marketing product” under Lanham Act). 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). Leading Market Technologies, Inc. , In United States v.

Production 52

Production International Trials Government 52

Drug & Device Law

OCTOBER 20, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. As Bexis put it: In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. That’s why Buckman Co. E.g., Estee Lauder, Inc.

FDA 59

FDA FDA Approval Pharmaceuticals Clinical Trials 59

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . 247d-6d(b)(8). Strike two. The suit “relates to” – at least – “the. . . distribution, sale, . . Strike three.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

AUGUST 24, 2023

Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention , a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams. at *8-10. at *14 (citation omitted).

Testimonials 52

Testimonials International Treatment Production 52