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Regulatory Update | 10 May 2012

Japan: English Translation of First-in-Human Studies Guidance Released

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Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is announcing the publication of an English translation of a guidance document detailing how first-in-human studies are to be conducted.The [Read More...]

Tags: Clinical Trials First-in-Human Guidance Japan PMDA Testing
Regulatory Update | 10 May 2012

Brazil: Regulation To Foster Innovation

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Brazil’s reorganized national regulatory agency, Anvisa, said in remarks it is focused on establishing “a regulatory environment conducive to innovation."The remarks, by Anvisa’s CEO Dirceu Barbano, [Read More...]

Tags: 2012 Anvisa Brazil Innovation Regulatory
Latest News | 10 May 2012

Senators Launch Investigation Into ‘Dubious Marketing Practices’ of Pain Pill Manufacturers

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Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & [Read More...]

Tags: American Pain Foundation Baucus Collusion Congress drug Endo Pharmaceuticals Grassley Investigation J&J Johnson & Johnson Letter Pain Pain Pharmaceutical Purdue Pharma Senate
Latest News | 10 May 2012

FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

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The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen [Read More...]

Tags: Delay FDA Implementation OIRA SPF Sun Screen Sunscreen Sunstein White House
Latest News | 10 May 2012

House Committee to Vote on User Fee Bill, Aiming for Passage in July

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The US House of Representatives’ Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) [Read More...]

Tags: Bill BIPUFA BsUFA Congress drug FDA FDA Reform Act of 2012 FDASIA GDUFA House Legislation MDUFA Medical Device PDUFA Pharmaceutical Senate Upton User Fees
Latest News | 10 May 2012

Bill Introduced to Speed Development and Review of Breakthrough Therapies

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A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new “breakthrough [Read More...]

Tags: 351(a)(1) 505(i) Application Bilbray Bill Breakthrough Therapies Congress DeGette Designation drug FD&C Act FDA House INDA Pharmaceutical
Latest News | 10 May 2012

Agency Increasing Number of Supplement Inspections, Says Fabricant

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The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA’s [Read More...]

Tags: CGMP cGMPs Compliance Enforcement Fabricant FDA Inspections Supplement Supplements Warning Letters
Latest News | 9 May 2012

Report: FDA Taking Longer to Approve Drugs With ‘Unmet Medical Needs’

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A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve [Read More...]

Tags: Approval Times BCG CHI CNS drug Drug Approvals FDA GI Oncology PDUFA Pharmaceutical Priority Review report time
Latest News | 9 May 2012

Usability Upgrades Announced for EMA’s Website

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The European Medicines Agency (EMA) has announced it has rolled out several usability upgrades for its website, allowing regulatory professionals to access a host of new and customizable features that [Read More...]

Tags: EMA Improvements RSS Search Upgrades Website
Latest News | 9 May 2012

FDA Cites Military-tech Company for Marketing Medical Device Without Approval

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A company marketing several medical devices intended to be used in combat situations has been cited by the US Food and Drug Administration (FDA) for marketing one without having sought approval from [Read More...]

Tags: 510(k) CGMP Deficiencies FDA H&H Associates Military PMA warning letter
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