On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et...more
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
What are the various factors impacting stakeholders in the direct access testing industry?
By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the...more
On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more