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By Gil Roth
Published July 31, 2012
No 483s at Clinical Pharmacology Unit Read More »
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
By Gil Roth
Published June 25, 2012
First U.S.-based packaging facility to handle CV, metabolic drugs Read More »
By Gary C. Messplay, J.D., Allison L. Reschovsky, J.D., and Adele M. Kaplan Gilpin, J.D., Ph.D., Hunton & Williams LLP
Published May 30, 2012
A new era of clinical trial transparency enforcement Read More »
Published May 18, 2012
Provides input at public hearing Read More »
By E. Morrey Atkinson, Ph.D., Cook Pharmica
Published May 4, 2012
. . . But do you know who you are? Read More »
Published May 3, 2012
Fill/finish line in Ireland to double Myozyme, Lumizyme capacity Read More »
By Gil Roth
Published May 3, 2012
Fill/finish line in Ireland to double Myozyme, Lumizyme capacity Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published March 16, 2012
Twaroski will serve as a scientist in the Washington, DC office Read More »
By Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
Published February 27, 2012
The FDA Modernization Act of 1997 reauthorized the collection of user fees by the FDA and amended the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices and biological products, an… Read More »
Published February 27, 2012
See Food and Drug Administration.… Read More »
Published February 13, 2012
No 483 observations issued Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March Read More »
By Gil Roth
Published January 17, 2012
Elder leaves agency after more than two decades Read More »
Published November 16, 2011
Also passes sixth product PAI Read More »
Published October 6, 2011
Vadodara site can now provide API manufacturing Read More »
Published September 15, 2011
Enhances global harmonization efforts Read More »
Published September 13, 2011
Facility is fully validated for manufacture of injectable sterile products Read More »
Published August 29, 2011
Pfizer NSCLC drug cleared, along with Abbott test Read More »
Published August 19, 2011
Joint inspection focused on increasing international regulatory collaboration Read More »
Published August 12, 2011
To manufacture a solid dose product for a client Read More »
By
Published August 11, 2011
Actions implemented at the site addressed manufacturing issues Read More »
Published August 10, 2011
No 483s at Scotland site Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
Published July 13, 2011
Chartwell Pharmaceuticals is now a registered pharmaceutical manufacturer with the FDA, effective March 15, 2011. Read More »
By Heather D. Bau00f1uelos
Published July 13, 2011
A busy year for the agency Read More »
Published July 5, 2011
DVT indication brings Lovenox-buster to U.S. market Read More »
By Gil Roth
Published July 5, 2011
DVT indication brings Lovenox-buster to U.S. market Read More »
Published June 15, 2011
Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA. Read More »
Published June 3, 2011
Haupt Pharma has successfully passed an inspection by the FDA at its Amareg site in Regensburg, Germany without any FDA-483 observation issued. Read More »
Published May 11, 2011
New trials are necessary for patient safety Read More »
Published May 4, 2011
Beijing Second Pharmaceutical Co., Ltd. (BSPC) has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc. Read More »
Published May 4, 2011
Beijing Second Pharmaceutical Co., Ltd. (BSPC) has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc. Read More »
Published May 2, 2011
A+ Secure Packaging’s LaVergne, TN facility has successfully completed a two-day cGMP compliance inspection by the FDA without any form 483 observations being issued. Read More »
Published April 25, 2011
GVK Biosciences has extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. Read More »
Published April 8, 2011
Pharma’s French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as contract test labs for extractables testing with the FDA. Read More »
Published April 7, 2011
GlaxoSmithKline and XenoPort, Inc. received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Read More »
Published April 7, 2011
GlaxoSmithKline and XenoPort, Inc. received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Read More »


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