News & Analysis as of

Manufacturers › Pharmaceutical Industry › Product Packaging

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

Vicente LLP on

We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

Arnall Golden Gregory LLP

Pharma Supply Chain Cornucopia: More FDA Guidance on DSCSA Product Identifier and Verification Requirements

Arnall Golden Gregory LLP on

So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Hogan Lovells

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations...more

Mintz - Health Care Viewpoints

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Mintz - Health Care Viewpoints on

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

6 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide