Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney

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.

Eli Lilly Terminates AIR Insulin Program

Mar 13, 2008

Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.

Active Ingredient in Baxter's Recalled Heparin Made in China

Feb 21, 2008

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.

FDA Again Denies Merck’s Request for OTC “Mevacor”

Feb 1, 2008

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.

Congressmen Call for Report on New Class of Drugs

Jan 24, 2008

Congressmen John Dingell and Bart Stupak have requested that the Government Accountability Office perform an updated assessment report in response to the US Food and Drug Administration?s potential development of a new class of behind-the-counter drugs.

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Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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