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Latest News
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14 May 2012
FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised
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The US Food and Drug Administration (FDA) has placed new contraindications on Novartis’ Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon
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3 February 2012
Reuters: French Regulatory Authority, Executives Searched In Mediator Probe
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The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier’s anti-diabetes drug Mediator,
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Health Canada, Facing Budget Cuts, Lays off Hundreds of Employees
25 April 2012
New Canadian Regulations Would Dramatically Expand Prescribing Authority
14 May 2012
Study: 510(k) Clearance Down 12% Since 2006, Time for Approval Up 40%
17 January 2012
Regulatory Focus: Week in Review (16-20 April)
20 April 2012
Regulatory Focus: Week in Review (9-13 April)
13 April 2012
Regulatory Focus: Week in Review (26-30 March)
30 March 2012
Regulatory Focus: Week in Review (2-6 April)
6 April 2012
Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup
20 January 2012
Most Viewed
France: New Agency to Soon Replace AFSSAPS
1 May 2012
Obama Signs Order Promoting International Regulatory Cooperation
1 May 2012
Choosing the Right Regulatory Career: An Inside Look
17 February 2012
FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act
9 February 2012
FDA Provides New Guidance for Promotional Labeling and Advertising
25 January 2012
RAPS Scope of Practice Study: Tracking the Regulatory Profession
22 February 2012
UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices
6 January 2012
FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA
13 January 2012