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Latest News
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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
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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
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21 May 2012
World: Regulatory Agencies Attend WHO Seminar
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Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate.The meeting, an international
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21 May 2012
Poll: More Than Half of Americans Favor Increased Regulatory Authority for States
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A poll conducted by Rasmussen Reports finds a slim majority of Americans are in favor of increasing the authority given to states to overrule a decision made by the US Food and Drug Administration
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18 May 2012
Regulatory Focus: Week in Review (14-18 May)
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Regulatory Focus is proud to bring you another edition of Week in Review—a recap of the global regulatory news space for the preceding week. We cover the news and regulatory intelligence from around
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18 May 2012
‘Job-Killing’ Safety Regulations Not So Job-Killing, Says Study
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A new study published in the journal Science looking at safety regulations at worksites in California shows companies making an effort to strengthen safety measures for their employees cut down on
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17 May 2012
Security Agency Warns About Medical Device Vulnerabilities
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The US Department of Homeland Security (DHS) issued a warning on 4 May regarding the potential for medical devices to be compromised by hackers, saying “health care entities need to take [the threat]
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15 May 2012
Researchers Gauge Effects of Regulatory Systems on Counterfeit Medicines
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A new paper exploring counterfeit and substandard medicines shows the presence of even a minimally-developed regulatory program can have a profound impact on ensuring consumers have access to genuine,
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14 May 2012
CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations
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A report released by the Ombudsman’s Office of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they
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14 May 2012
Brazil: South American Countries Driving Regulatory Harmonization
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Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries’ efforts in the region.Both Brazil’s and
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12
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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