Frederick Ball

Frederick Ball

Duane Morris LLP

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FDA Issues Draft Guidance for Identification and Notification of Suspect Products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6/25/2014 - Draft Guidance DSCSA FDA Notice Requirements Prescription Drugs

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from...more

6/23/2014 - ANDA FDA Pharmaceutical Patents Prescription Drugs

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The U.S. Food and Drug Administration (FDA) recently published its response to three citizen petitions and its draft Guidance for Industry relating to the determination of the five-year new chemical entity (NCE) exclusivity...more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

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

7/18/2013 - Administrative Fines Detention Drugs FDA FDASIA Pharmaceutical

FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...more

6/19/2013 - CGMP Drug Manufacturers FDA FDCA Prescription Drugs Required Documentation

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

3/6/2013 - Affordable Care Act CMS Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Reporting Requirements Research Funding Sunshine Act

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

1/7/2013 - DOJ Drug Compounding FDA FDCA Officers Park Doctrine Pharmacies

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