Carolyn Alenci

Carolyn Alenci

Duane Morris LLP

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FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings

On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate...more

8/12/2014 - Administrative Procedure Act FDA FDCA Pharmaceutical Pharmaceutical Manufacturers Rulemaking Process

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....more

8/5/2014 - Drug Manufacturers FDA GDUFA Generic Drugs Pharmaceutical Prescription Drugs

FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within...more

6/25/2014 - Draft Guidance DSCSA FDA Notice Requirements Prescription Drugs

Supreme Court Establishes "Totality of the Circumstances" Framework for Determining Whether Attorney's Fees Should Be Shifted in...

Also Holds That Review of Such Determinations Is for Abuse of Discretion - In a pair of companion cases decided on April 29, 2014, the U.S. Supreme Court provided key guidance on several significant issues concerning...more

5/7/2014 - Attorney's Fees Brooks Furniture Exceptional Case Fee-Shifting Statutes Highmark v. Allcare Octane Fitness v. ICON Patent Litigation Patents SCOTUS

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

4/14/2014 - FDA Pharmaceutical Prescription Drugs Security Supply Chain

FDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of Federal Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration (FDA) recently published its response to three citizen petitions and its draft Guidance for Industry relating to the determination of the five-year new chemical entity (NCE) exclusivity...more

2/27/2014 - Exclusive Dealing Agreements FDA FDCA Prescription Drugs

FDA's Guidance for Industry Concerning Receipt Dates

The U.S. Food and Drug Administration (FDA) on February 10, 2014, published its Guidance for Industry on the receipt date for regulatory submissions. The Guidance applies to submissions that are in electronic or paper format,...more

2/14/2014 - ANDA FDA Pharmaceutical Prescription Drugs

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