Articles by Susan Haigney - Pharmaceutical Technology

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Articles by Susan Haigney

FDA Recommends Three Drug User Fee Programs

Jan 19, 2012

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.

FDA Creates Shared REMS System for TIRF Medicines

Jan 5, 2012

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

Drug Diverter Sentenced to 70 Months in Prison

Feb 25, 2010

Arnesto Segredo of Miami, Florida, was sentenced to 70 months in prison for conspiring to divert prescription drugs.

EMEA Recommends Two H1N1 Vaccines for Authorization

Oct 1, 2009

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

GlaxoSmithKline and Pfizer Create New HIV-Focused Company

Apr 23, 2009

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to create a new HIV-focused drug company.

Growth of US Prescription Sales Slow in 2008

Mar 26, 2009

On March 19, 2009, IMS, the leading provider of market research for the pharmaceutical and healthcare industries, reported that annual sales of prescriptions in the US grew 1.3% from 287.6 billion in 2007 to 291.5 billion in 2008.

Governor Kathleen Sebelius Nominated for Secretary of HHS

Mar 5, 2009

President Obama nominated Kansas Governor Kathleen Sebelius as his new Secretary of Health and Human Services (HHS).

FDA Comments on ICH Q4B Draft Annexes

Feb 26, 2009

The US Food and Drug Administration stated its considerations in regards to the three draft annexes to the International Conference on Harmonization's Q4B document.

Congressman Questions FDA's Heparin Investigation

Nov 26, 2008

In a letter to Acting Comptroller General Gene Dodaro dated November 19, 2008, Congressman Joe Barton (R-Texas) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration's handling of the highly-publicized, tainted heparin scare that occurred in 2007 and 2008.

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