article thumbnail

Oregon-based medical group Northwest Permanente announces affiliation with The Permanente Medical Group of Northern California

Permanente Medicine

Affiliation will allow groups to drive high-value care and innovation PORTLAND, ORE, April 16, 2025 – Oregon-based Northwest Permanente (NWP) and The Permanente Medical Group (TPMG) of Northern California announced a formal affiliation today. Most transactions are largely focused on size, scale, and finance.

Medical 52
article thumbnail

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

article thumbnail

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. The CSA establishes classifications for drugs based on their potential for abuse relative to their legitimate medical use. 21 U.S.C. §

article thumbnail

Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. Cochrane Database of Systematic Reviews Review.

article thumbnail

Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W. 2009 Nov;27(4):655-67, ix. doi: 10.1016/j.emc.2009.07.003.

article thumbnail

Identifying and Resolving Red Flags: DEA Continues to “Run it Up the Flagpole”

FDA Law Blog

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 29, 2009)). Cocktail Medications. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos.

IT 40