Sep 11, 2008
By:
Susan Haigney
The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007.
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Jun 5, 2008
By:
Susan Haigney
The California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients.
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May 20, 2008
By:
Susan Haigney
The devastating May 12 earthquake that struck the Wen Chuan Sichuan province of China left tens of thousands dead, homes and businesses destroyed, and survivors without basic human needs such as shelter, food, and medicines. The quake also had a significant impact on the local industries of the region. Pharmaceutical companies located within the affected areas are assessing possible damage to facilities and loss of personnel.
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Apr 22, 2008
By:
Susan Haigney
The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA Form 3674 when submitting documentation to the Agency in order to comply with FDAAA, Title VIII.
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Apr 16, 2008
By:
Susan Haigney
The US Food and Drug Administration appointed Frank M. Torti, M.D., M.P.H, as principal deputy commissioner and chief scientist. Torti's appointment with FDA will begin in May.
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Apr 10, 2008
By:
Susan Haigney
In an ongoing effort to secure the safety of prescription drugs, the US Food and Drug Administration has released its draft five-year plan under the Prescription Drug User Fee Act (PDUFA).
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Apr 3, 2008
By:
Susan Haigney
The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.
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Mar 13, 2008
By:
Susan Haigney
Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.
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Feb 21, 2008
By:
Susan Haigney
The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International Inc.'s recalled drug Heparin was made in a plant in China.
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