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Food and Drug Administration (FDA) › 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

Dechert LLP

Dechert Re:Torts - Issue 14

Dechert LLP on

A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

Womble Bond Dickinson

Take a Bite out of Crime: There’s More than One Way to Stem the Flow of Counterfeit Medications

Womble Bond Dickinson on

A growing problem in the U.S. is the widespread availability of counterfeit medications, or fake prescription pills. These drugs, made to look like authentic prescription medications, may contain no active ingredient or any...more

BakerHostetler

FDA and Pharmacy Weekly Digest - August 2019 #3

BakerHostetler on

Food/Dietary Supplements - FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy for the FDA stated, “We’ve seen rapidly growing interest in marketing...more

Hogan Lovells

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents,...

Hogan Lovells on

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...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

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