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Biological Risk Evaluation and Management for Medical Devices

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European Ombudsman Accuses EMA of Not Granting Public Access to Drug Safety Data

September 23, 2014

The European Ombudsman has accused EU regulators of blocking access to drug safety reports and other public documents in a new case that observers tell DID is part of the watchdog’s ongoing effort to bring greater transparency to the pharmaceutical industry. Read More

India’s NPPA Withdraws Internal Guidelines on Price Controls

September 23, 2014

India’s drug regulatory authority has abruptly withdrawn a guideline for setting prices on many branded-generic drugs, a move that could help manufacturers press their case in a lawsuit against the government’s drug-pricing policies. Read More

Two More Congressmen Voice Opposition to Proposed Generic Labelling Rule

September 23, 2014

Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More

Generics Makers Concerned About FDA’s Inactive Ingredient Database, Other GDUFA Issues

September 23, 2014

Database needs a complete overhaul, generics makers say. Read More

Australia Issues Amended Guidance on Nonclinical Studies

September 22, 2014

Drug sponsors applying to include products on the Australian registry should submit both favorable and unfavorable information with their nonclinical study reports, according to amended guidance. Read More

FDA Outlines Goals for Improving REMS Communications

September 22, 2014

The FDA said it plans to create a central database with information on how different parties experience risk evaluation and management strategies, a project that is part of the agency’s effort to improve communications around REMS requirements and activities. Read More

Group Urges European Regulators to Develop Guidance on Biosimilar Labeling

September 22, 2014

A European biotech association is calling on EU regulators to develop new guidance on the labeling of biosimilars that will end the practice of assigning a generic label to the complex products. Read More

FDA Says Continuum of Biosimilarity Ratings Do Not Represent Approval Standards

September 22, 2014

FDA officials sought to clear up questions about what standards the agency will apply when approving biosimilars, emphasizing that manufacturers must prove their products are “highly similar” to the reference product in order to win a green light. Read More

NIH Seeks Pharma’s Cooperation in Pill ID Project

September 19, 2014

The National Institutes of Health is asking pharmaceutical manufacturers, wholesalers and repackagers to submit samples of their pills as part of an ongoing push to better identify drug products. Read More

FDA Advisory Panels Reject Testosterone Replacement Therapy

September 19, 2014

Two FDA advisory panels last week overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy. Read More

FDA Closes GDUFA Donut Hole, Sets Deadlines for 2012, 2013 ANDAs

September 19, 2014

The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More

House Bill Seeks to Eliminate REMS as Anti-Generic Tool

September 19, 2014

A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More

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Regulatory Affairs
RSS

European Ombudsman Accuses EMA of Not Granting Public Access to Drug Safety Data

India’s NPPA Withdraws Internal Guidelines on Price Controls

Two More Congressmen Voice Opposition to Proposed Generic Labelling Rule

Generics Makers Concerned About FDA’s Inactive Ingredient Database, Other GDUFA Issues

Australia Issues Amended Guidance on Nonclinical Studies

FDA Outlines Goals for Improving REMS Communications

Group Urges European Regulators to Develop Guidance on Biosimilar Labeling

FDA Says Continuum of Biosimilarity Ratings Do Not Represent Approval Standards

NIH Seeks Pharma’s Cooperation in Pill ID Project

FDA Advisory Panels Reject Testosterone Replacement Therapy

FDA Closes GDUFA Donut Hole, Sets Deadlines for 2012, 2013 ANDAs

House Bill Seeks to Eliminate REMS as Anti-Generic Tool

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Events

Editor's Picks

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