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Regulatory
107 Articles Available
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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
Regulatory
FDA Approves Admelog, The First Short-Acting "Follow-On" Insulin Product To Treat Diabetes
PR-M12-17-NI-008
Regulatory
Booklet Label Combines Tamper-Protection And Drug Information
PR-M12-17-NI-004
Oncology
Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma
PR-M12-17-NI-006
Biosimilars
Boehringer Ingelheim’s Adalimumab Biosimilar Wins First EU Approval
PAO-M11-17-NI-045
Drug Development
Small Molecule Cancer Combination Therapy Receives Second Patent
PAO-M11-17-NI-031
FDA
First Treatment for Rare Blood Disorder Approved by FDA
PAO-M11-17-NI-026
Diagnostics
Ultrasound Transducer from Butterfly Network Receives FDA Approval for 13 Applications
PAO-M11-17-NI-023
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