National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

The Drug Abuse Treatment Act of 2002, for instance, enabled the newly approved medication buprenorphine, developed through NIDA research, to be prescribed by regular physicians if they obtained a waiver. People in rural communities may have particular difficulty accessing care. Most of the fatal overdoses each year involve opioids.

Science 127

Science FDA Approval Treatment Research 127

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. The federal telemedicine flexibilities (i.e., Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations.

FDA Approval 52

FDA Approval Regulations Pharmacy Licensing 52

Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. 2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. Pharmacy v. Mukasey , 536 F.3d

Compounding Pharmacies 59

Compounding Pharmacies Pharmacy FDA Approval FDA 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Lederle Laboratories , 2008 WL 972657 (W. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. 2d at 401.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. See this post on one of our decisions from 2008.) Hiedeman, 694 F.3d 3d 1004 (9th Cir. 3d 406 (6th Cir.

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FDA Approval Pharmacy FDA Drugs 127