Angie Drakulich

The US Food and Drug Administration opened another foreign office, this time in Mexico City.

The Government Accountability Organization (GAO) has recommended the FDA Commissioner to develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE) to help address weaknesses in the agency?s oversight of postmarket drug safety.

The Government Accountability Office recommended that the US Food and Drug Administration Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs to the Office of Surveillance and Epidemiology to address weaknesses in the agency's oversight of postmarket drug safety.

The EMEA unveiled several changes to the organization, including a new structure and visual identity.

The European Medicines Agency unveiled several changes to the organization, including a new structure and visual identity.

Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, the ICH has benefited regulatory authorities.

Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.

The FDA has issued 22 Warning Letters to website operators as part of its International Internet Week of Action, a week-long international effort aimed at curbing illegal actions involving medical products.

The US Food and Drug Administration has issued 22 Warning Letters to website operators as part of its International Internet Week of Action.

The international pharmaceutical supply-chain consortium Rx-360 has launched in Europe; with more than 135 industry and regulatory representatives attending to discuss the global impact of counterfeit drug products.

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance.

Novartis (Switzerland) plans to invest $1 billion during the next 5 years to increase R&D activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

The International Conference on Harmonization (ICH) has adopted pharmacopeial text annexes after a meeting of the steering committee and expert working groups last week.

Novartis (Basel, Switzerland) plans to invest $1 billion over the next five years to increase research and development activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.

The FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a report from the Government Accountability Office (GAO).

The US Food and Drug Administration needs to enhance its oversight of drugs approved on the basis of surrogate endpoints, according to a September report from the Government Accountability Office (GAO) that was released this week.

The FDA issued a guidance for industry and review staff titled, 'Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information'.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

IMS Health delivered some good news last week with its updated pharmaceutical market forecast.

The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.

Officials from the US Food and Drug Administration discuss best practices for applying quality-by-design concepts. This article contains bonus online-exclusive material.

Contract research organizations such as Covance are heading further east through Europe.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

This article is part of a Special Report on the Emerging Markets of The East, October 2009

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.