Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

Exeed Regulatory Compliance

MARCH 5, 2020

It rapidly caused a widespread epidemic in China and has spread to over 50 countries outside of China with more than 90,000 confirmed cases and 3000 deaths at the time of this blog article. This is where FDA’s Emergency Use Authorization (EUA) comes into play and offers an opportunity for the medical industry to rally and help.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

SQA

AUGUST 8, 2023

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. American Home Products , 2005 WL 2277518, at *11 (S.D. 16, 2005); Huntman v. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

APRIL 21, 2022

As readers of this blog are aware, case law is divided over whether alleged CGMP violations can ever support a non-preempted claim (with the more persuasive cases holding that they cannot). Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. 2022 WL 1076173, at *5.

FDA 59

FDA Fraud 59

Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

JUNE 2, 2023

3d 411, 422-23 (2005). So, why does the Drug and Device Law Blog care? We’ve often said that we like preemption being a question of law because, on the whole, we expect that our FDA-related facts will more persuasive than the other side’s, so we want courts to decide these issues as soon as possible. Varghese v. Not anymore.

FDA 59

FDA 59