Regulatory Articles - Applied Clinical Trials

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Regulatory Articles

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.

Working Toward a Better Future

October 1, 2009

The EU struggles to get over its regulatory hurdles in an effort to further R&D success.

Keys to Drug Development in Latin America

October 1, 2009

The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.

FDA Promotes Integrity and Compliance

October 1, 2009

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

EMEA and FDA Team Up on GCP

September 1, 2009

The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections.

FDA Takes on Addiction

September 1, 2009

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

Global Development Challenges Sponsors

September 1, 2009

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

Regulating the Generic Drug Process

September 1, 2009

Guidance for the design and conduct of international bioequivalence trials.

The eCTD Advantage

August 20, 2009

Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND.

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