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Regulatory
114 Articles Available
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Partnership
Yseop and Litera Partner to Fast-Track Regulation Submission Processes for Life Sciences Companies
PR-M01-20-NI-011
Glocalization
From Regulatory Convergence to Global Regulatory Harmonization
PAP-Q3-19-NI-004
Manufacturing Technology
Q: How does your company manage to provide local services/support while still efficiently managing global compliance?
PAP-Q2-19-NI-006
Novel Therapies
Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?
PAP-Q2-19-NI-007
Regulatory
Are EMA and FDA Decisions Diverging?
PAO-M08-19-NI-037
Fecal Transplant
Fecal Transplant Associated with One Patient Death
PAO-M06-19-NI-020
Regulatory
Regulatory Spotlight: Following the Tobacco Road
PAP-Q2-2019-NI-005
Regulatory Spotlight
Understanding the FDA’s Approach to Real-World Evidence
PAP-Q1-2019-NI-008
Opioids
Statement from FDA Commissioner Scott Gottlieb, M.D. on the Agency's 2019 policy and Regulatory Agenda for Continued Action to Forcefully Address Opioid Abuse
PR-M02-19-NI-061
Serialization
Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate
PAP-Q4-18-NI-011
FDA Approval
FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 years old
PR-M10-18-NI-032
Regulatory
Competitive Generic Therapy: A New Patient-Centric FDA Pathway
PAP-Q3-18-NI-008
Regulatory
Meeting Regulatory Requirements: Rising to the Challenge with a Trusted Equipment Partner
PAP-Q3-18-CL-016
Drug Pricing
New Senate Bill Includes Amendment on Drug Pricing in Ads for Prescription Meds
PAO-M08-18-NI-026
Regulatory Approval
CERENOVUS Receives European Regulatory Approval For BRAVO Flow Diverter to Treat Intracranial Aneurysms
PR-M08-18-NI-088
Regulatory
Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen
PR-M08-18-NI-093
Regulatory
China to Accelerate Review of 48 Foreign Drugs
PAO-M08-18-NI-013
China
Big Pharma Companies Taking New Drugs to China First
PAO-M08-18-NI-010
Regulatory
Reducing Time to Market with Targeted Regulatory Affairs Support
PAO-06-18-CL-003
Regulatory
Compliance at Hovione, Annual Inspection Review
PR-M03-18-NI-037
Regulatory
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
PR-M01-18-NI-060
Research
Medical Research Collaborating Center Selects Medidata to Meet Global Regulatory Requirements During Clinical Trials
PR-M01-18-NI-037
Regulatory
FDA Approves New Pfizer Biosimilar
PR-M12-17-NI-010
Regulatory
Vedanta Biosciences Granted Four New U.S. Patents Expanding Coverage for Compositions and Methods of Use for Therapeutics
PR-M12-17-NI-009
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