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Latest News | 22 May 2012

US, Mexico Announce Plan to Strengthen Regulatory Cooperation

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US Health and Human Services Secretary Kathleen Sebelius and Mexico’s Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation [Read More...]


Latest News | 22 May 2012

Report: India Moving to Regulate Biotechnology Research

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The Indian government is preparing to establish a new regulatory agency in charge of regulating biotechnology product research, transport, import, manufacture and use, reports The Economic Times.The [Read More...]


Latest News | 22 May 2012

NICE Fires Back at Study, Claims its Approval Times Are Steadily Falling

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The National Institute for Health and Clinical Excellence (NICE) is aggressively firing back at a study released which claimed the health technology assessment (HTA) body was taking an average of five [Read More...]


Latest News | 22 May 2012

Health Canada Consolidates Guidance on Comparative Bioavailability Standards

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Health Canada released new, consolidated guidance regarding how sponsors should conduct and analyze comparative bioavailability studies used to support applications for generic medications.The 22 May [Read More...]


Latest News | 22 May 2012

User Fee Bill Advances to Vote in Senate

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The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate’s iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving [Read More...]


Latest News | 22 May 2012

EMA Releases Guidance on Electronic Submission of Veterinary Applications

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The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.The document, [Read More...]


Latest News | 22 May 2012

Report: Insufficient Regulatory Oversight Partially Responsible for Counterfeit Drugs

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An article published in The Lancet Infectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate [Read More...]


Latest News | 22 May 2012

States to FDA: Appeal Enforcement Discretion Decision

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A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge’s decision in a lawsuit against both FDA and the states’ ability [Read More...]


Latest News | 22 May 2012

Reviewers Express Doubts in Advance of Xarelto Review

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An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson’s (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary [Read More...]


Latest News | 21 May 2012

PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

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The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency’s proposal to review [Read More...]


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