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US

REMs: Battling the Unknowns

October 22, 2009

Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.

Pressure Mounts for ICH GCP Revisions

October 1, 2009

The ICH GCP guideline continues to age and while members of the Institute of Clinical Research voice the need for its revision, industry debates whether changes are necessary.

FDA Promotes Integrity and Compliance

October 1, 2009

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

FDA Takes on Addiction

September 1, 2009

Abuse and misuse of extended-relief opioids, get regulatory attention and potential guidance from Onsolis' REMS.

Regulating the Generic Drug Process

September 1, 2009

Guidance for the design and conduct of international bioequivalence trials.

Global Development Challenges Sponsors

September 1, 2009

International health crises expand testing of new vaccines and drug treatments for third-world diseases.

REMS Group Offers Consulting Services

August 21, 2009

FDA Proposes Mandatory Electronic Safety Reporting

August 21, 2009

WHO Boosts Research in Africa

August 1, 2009

Vital players come together in an attempt to find a cure for a devastating illness predominantly effecting African countries.

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