Tag: CDER

7
Nov

FDA Generic and New Drug Approvals-7 November 2015

FDA’s Recent Approvals New Drug and Generic Approvals Date:             November 7, 2015 The following provides FDA links (downloadable below in PDF) to approval information for recent generic and new drug applications. November 5, 2015 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Advil ibuprofen sodium Tablet;Oral Pfizer Cons Hlthcare Manufacturing Change or Addition Carbaglu carglumic acid Tablet;Oral Orphan Europe

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22
Oct

Oral Suspension Approved to Treat Too High Amount of Potassium in the Blood

Veltassa Patiromer for oral suspension (Powered Medication) On October 21, 2015, the U.S. Food and Drug Administration approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The

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16
Oct

FDA Small Business REdI Conference-November 2015

FDA Small Business Regulatory Education for Industry (REdI) Conference “Prescription Drug Labeling – Challenges and Issues”, November 3-4, 2015 This 2 day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion CDER Small Business and Industry Assistance (SBIA) invites you to attend our two-day November 3rd/4th Regulatory Education for

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4
Mar

FDA Launches Mobile App for Drug Shortages

 On March 4, 2015, the United States Food and Drug Administration (FDA) announces it launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies the following: current drug shortages, resolved shortages, and discontinuations of drug products. Drugs in short supply can delay or deny needed care for patients. Drug shortages

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7
Jan

FDA CDER List of Guidances to Publish in 2015

Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015 By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr)  CATEGORY —Advertising Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs Health

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1
Aug

FDA’s Drug Approval Process Is Now Faster Than Anywhere Else In the World

By Admin Dr. Janet Woodcock, M.D., before the Subcommittee on Health, House Committee on Energy and Commerce She stated: FDA’s approval process is now faster than anywhere else in the world (see figure below). Just last year, three-quarters of the new drugs FDA approved were approved in the United States before the European Union (EU) and Japan. Currently 90 percent of drugs

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