Eli Tomar

Eli Tomar

Akin Gump Strauss Hauer & Feld LLP

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FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

2/20/2015 - Biologics DQSA Draft Guidance Drug Compounding Drug Manufacturers FDA FDCA Outsourcing Pharmaceutical Pharmaceutical Manufacturers Pharmacies Premarket Approval Applications Prescription Drugs

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

11/25/2014 - Draft Guidance Drug Compounding FDA FDCA Final Guidance Outsourcing Facilities Pharmacies Registration Reporting Requirements Section 503

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

7/3/2014 - CGMP DQSA Drug Compounding Drug Manufacturers FDA Manufacturers Outsourcing Pharmaceutical Prescription Drugs

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