Kathleen Peterson

Kathleen Peterson

Cooley LLP

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FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

7/3/2014 - DQSA Draft Guidance Drug Compounding FDA Final Guidance Pharmaceutical pharmacie Proposed Regulation

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

5/27/2014 - 340B Affordable Care Act Covered Entities FFDCA HHS HRSA Orphan Drugs Pharmaceutical Manufacturers

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