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Regulatory Update
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9 May 2012
European Commission: Consultation on Stakeholder Participation In HTA Network
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The European Commission is requesting input from stakeholders, including drug and device companies, as to “how the consultation with stakeholders in the Health Technology Assessment (HTA) network’s
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CER
Directive 2011/4
European Commission
Health Technology Assessment
HTA
Input
Stakeholder
Regulatory Update
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27 April 2012
EC: SCENIHR Issues Memorandum on Europe’s Scientific Risk Assessment Process
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A memorandum issued by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is intended to provide transparency to stakeholders on the Committee risk
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EC
Europe
European Commission
Health RIsks
Memorandum
Risk
Risk Assessment
SCENIHR
Latest News
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2 March 2012
EC Proposes Streamlining Pricing, Reimbursement Decisions
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The European Commission (EC) wants drugs to reach the market faster and is proposing changes to the pricing and reimbursement process.In a report by PMLive Intelligence Online, revisions to the
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EC
Europe
European Commission
market
Pricing
Reimbursement
Latest News
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3 February 2012
EC Investigation of PIP Implants Inconclusive, Calls for Further Study
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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast
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Breast Implant
EC
European Commission
France
French
Investigation
PIP
Poly Implant Prothese
report
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Most Viewed
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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