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Latest Center for Drug Evaluation and Research Stories

2014-08-13 08:29:24

WASHINGTON, Aug. 13, 2014 /PRNewswire/ -- The National Organization for Rare Disorders (NORD) today announced the agenda for the Rare Diseases and Orphan Product Breakthrough Summit, to be held October 21-22, 2014 at the Hilton Mark Center in Alexandria, VA. Photo - http://photos.prnewswire.com/prnh/20140812/135518 This annual event is the innovative hub for all stakeholders in the rare disease and orphan products community - providing an educational platform for pharmaceutical, biotech,...

2014-06-27 08:23:26

NEW YORK, June 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA), based in Silver Spring, Maryland provides a variety of public health services in the United States through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter (OTC) pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics and veterinary...

2014-06-26 23:07:13

Catalent Pharma Solutions, the global leader in drug development solutions and advanced delivery technologies for pharmaceutical, biologic and consumer health products, was recently invited by the FDA Office of Compliance and Biologics Quality to speak at its Manufacturing Technology Seminar Series. The FDA had specifically requested that Catalent present on its ADVASEPT™ technology, for the advanced aseptic filling of injectable drugs, and Zydis®, Catalent’s Fast Dissolve...

2014-06-18 16:27:02

BETHESDA, Md., June 18, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference. Besides the Office for Drug Evaluation and Research (CDER), the FDA Centers for Biologics Evaluation and Research (CBER), Devices and Radiological Health (CDRH), and Veterinary Medicine (CVM), along with the Office of Regulatory...

2014-06-09 12:31:09

ATLANTA, June 9, 2014 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA)(1) for Tranexamic Acid Injection 1000 mg/10mL (100 mg/mL). The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent - therefore, therapeutically equivalent - to the reference listed drug, CYKLOKAPRON® - Tranexamic Acid Injection Solution (Pharmacia & Upjohn, Inc.). Tranexamic Acid...

2014-05-13 23:02:01

Sessions to provide key regulatory updates from international leaders Washington (PRWEB) May 13, 2014 Leading drug and medical device regulators from around the world will offer insight on their home countries’ and continents’ regulatory landscape during town hall sessions at the DIA 2014 50th Annual Meeting, from June 15 to 19 at the San Diego Convention Center. Regulatory innovators from the U.S., Europe, Canada and Asia will lead the discussions. Guido Rasi, executive director of...

2014-03-11 23:01:19

Janet Woodcock will discuss reorganization to consolidate quality-related functions. Horsham, PA (PRWEB) March 11, 2014 The U.S. Food and Drug Administration’s (FDA) Janet Woodcock will lead a discussion of the mission and function of FDA’s new Office of Pharmaceutical Quality at the DIA 2014 50th Annual Meeting in San Diego, to be held June 15 to 19. Woodcock is director of FDA’s Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription...

2014-02-13 08:31:16

Former FDA Director of the Division of Reproductive and Urologic Products/CDER, Dr. Daniel A. Shames Joins Agile Therapeutics Scientific Advisory Board PRINCETON, N.J., Feb. 13, 2014 /PRNewswire/ -- Agile Therapeutics, a specialty pharmaceutical company focused on women's health, announced today that Daniel A. Shames M.D., F.A.C.S., has joined its Scientific Advisory Board. Dr. Shames is an experienced clinician with extensive experience in pharmaceutical development and regulatory affairs....

FDA Approves Novel AstraZeneca, Bristol-Meyers Squibb Diabetes Drug
2014-01-10 11:37:58

Ranjini Raghunath for redOrbit.com - Your Universe Online The FDA has approved the use of a new Type 2 diabetes drug called Farxiga, developed by pharmaceutical companies Bristol-Meyers Squibb and AstraZeneca. Type 2 diabetes affects 24 million people in the US and nearly 350 million people worldwide. Conventional diabetes drugs work by reducing the amount of sugar the body absorbs from food or by boosting the production of insulin which disposes of excess sugar. Farxiga, however,...

2013-12-20 23:00:49

ISPE studies on Drug Shortages and Quality by Design were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug Evaluation and Research (CDER), in her statement associated with her testimony to the U.S. Congressional Committee on Oversight and Government Reform’s Subcommittee on Energy Policy, Health Care and Entitlements. Tampa, Fla. USA (PRWEB) December 20, 2013 Two recent ISPE studies were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug...


Word of the Day
lunula
  • A small crescent-shaped structure or marking, especially the white area at the base of a fingernail that resembles a half-moon.
This word is a diminutive of the Latin 'luna,' moon.
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