Remove Compliance Remove Licensing Remove Regulations
article thumbnail

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog: Biosimilars

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. California Stem Cell Treatment Center, Inc., 21 U.S.C. § See 21 C.F.R.

article thumbnail

Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

Insiders

Sign Up for our Newsletter

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

article thumbnail

DFS500 Amendments: What You Need to Know

Perficient: Drug Development

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

article thumbnail

NYSDFS Part 500 Cyber Amendments Finalized: What You Need to Know

Perficient: Drug Development

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

article thumbnail

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

article thumbnail

HCL Commerce Modpack Upgrade To 9.1.x.x

Perficient: Drug Development

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Accept the license agreement and click Next. Performance Improvements: Updates often include performance enhancements that make the platform faster and more reliable. Click Next.