Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney

FDA Outlines Rules on Genetically Engineered Animals

Sep 25, 2008

In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18.

FDA Issues Warning Letters and Import Alert on Ranbaxy Laboratories

Sep 18, 2008

The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.

FDA Updates Bioequivalence Guidelines

Sep 11, 2008

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.

California Senate Passes Bill That Would Amend the State Confidentiality of Medical Information Act

Jun 5, 2008

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.

China Earthquake Shakes Up Pharma Do-Gooders

May 20, 2008

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.

FDA Clarifies Certification Requirement

Apr 22, 2008

The US Food and Drug Administration issued a draft guidance to clarify the Agency's intensions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and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.

FDA Appoints New Chief Scientist

Apr 16, 2008

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.

FDA's Drug Safety Plan to Increase Post-Market Safety

Apr 10, 2008

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).

California's ePedigree Delayed

Apr 3, 2008

The deadline for the implementation of California's prescription drug tracking system, ePedigree, has been delayed until January 2011.


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