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April 9, 2020

CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Section 211.68 (automatic, mechanical, and electronic equipment) of […]
April 9, 2020

CPG Sec. 425.200 Computerized Drug Processing; Vendor Responsibility

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Computer systems used in the production and control […]
April 9, 2020

Free Speech Systems LLC d.b.a. Infowars.com – 605802 – 04/09/2020

Product: Drugs Recipient: Recipient Name Mr. Alexander E. Jones Free Speech Systems LLC d.b.a. Infowars.com 3005 S Lamar BlvdSte D109-398Austin, TX 78760-9549United States [email protected] Date:               […]
April 9, 2020

List of Drug Master Files (DMFs)

The list of DMFs, which is updated quarterly, contains DMFs received by March 31, 2020, for which acknowledgment letters were sent before April 7, 2020. The […]
April 9, 2020

S10 Photosafety Evaluation of Pharmaceuticals

Docket Number: FDA-2013-D-0068 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 9, 2020

Cardiovascular and Renal Drugs Advisory Committee Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
April 9, 2020

E2F Development Safety Update Report

Docket Number: FDA-2008-D-0386 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 9, 2020

Medical Imaging Drugs Advisory Committee Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
April 9, 2020

Clinical Evaluation of Antiepileptic Drugs (adults and children)

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]
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