Elinor Hart

Elinor Hart

Duane Morris LLP

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FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act...more

4/8/2014 - Drug Compounding FDA FDCA Fees Outsourcing Pharmaceutical Pharmaceutical Manufacturers

Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

Compounding Legislation Continues to See More Changes - The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding bill and signaling...more

7/30/2013 - Drug Compounding Drugs FDA FDCA Pharmaceutical

Compounding Legislation Goes Through Another Change: New House Bill on Federal Oversight

U.S. Rep Griffith Releases Revised Draft Bill Providing Federal Oversight over Compounding Pharmacies - On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill ("Griffith...more

7/22/2013 - Drug Compounding Drug Manufacturers FDA FDAMA FDCA Memorandum of Understanding New Legislation Pharmacies

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On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs.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

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

4/30/2013 - Drug Compounding Drug Manufacturers FDCA Penalties Proposed Legislation

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

3/21/2013 - Drug Compounding FDA FDAMA FDCA Patient-Specific Prescriptions

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