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Regulatory

105 Articles available
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
FDA

FDA, European Regulators Align for More Efficient GMP Inspections

PAO-M11-17-NI-002
FDA Approval

Calquence, AstraZeneca’s BTK Inhibitor Approved by FDA

PAO-M11-17-NI-001
Regulatory

No Clinically Meaningful Difference: The Upward Trend of Biosimilars

PAP-Q4-17-FA-001
CAR-T

Breakthrough CAR-T Immunotherapy Approved

PAO-M10-17-NI-037
Drug Pricing

California Moves to Increase Transparency of Prescription Drug Pricing

PAO-M10-17-NI-030
FDA Approval

FDA Expands 510(k) Clearance for NuVasive’s Limb Lengthening Platform to Include Bone Transport

PAO-M10-17-NI-022
FDA Approval

FDA Approves New, Implantable Sleep Apnea Treatment

PAO-M10-17-NI-016
FDA

FDA Grants Priority Review to Gilotrif® For Uncommon EGFR Mutations in Advanced NSCLC

PR-M10-17-NI-002
FDA Approval

Novartis Receives First Ever FDA Approval For A CAR-T Cell Therapy, Kymriah(TM) (CTL019)

PR-M08-17-NI-010
FDA

FDA Finalizes Emerging Drug Manufacturing Technology Guidance

PAO-M10-17-NI-012
Innovation

New Plant Will Supply Large Numbers of Genetically Modified Mosquitos

PAO-M10-17-NI-008
FDA Approval

Eli Lilly Gets Early Approval for Breast Cancer Drug

PAO-M10-17-NI-006
FDA Approval

FDA Approves Grifols’ Prolastin-C Liquid

PAO-M09-17-NI-032
Biosimilar

FDA Approves First Biosimilar Treatment for Multiple Cancers

PAO-M09-17-NI-030
GSK Contract Manufacturing

GSK Shingles Vaccine Recommended for Approval by FDA Panel

PAO-M09-17-NI-027
Serialization

PCI Pharma Services Announces Release of Joint White Paper with Domino on Ink Leachability in Pharmaceutical Serialization

PR-M09-17-NI-008
Innovation

FDA Green Lights Mobile App to Help Treat Drug Abuse

PAO-M09-17-NI-022
ADC

Pfizer Gets Second ADC Approval in 2017

PAO-M09-17-NI-019
Innovation

Women Gain New Control Over Mammogram Discomfort

PAO-M09-17-NI-016
FDA

Collaborations within FDA Intended to Improve Facility Inspections and Facilitate Drug Approvals

PAO-M09-17-NI-010
FDA

FDA’s Gottlieb Weighs in on the Drug Quality and Security Act (DQSA)

PAO-M06-17-NI-018
Regulatory

Implications of Serialization for the U.S. Pharma Industry

PAP-Q2-17-CL-001
Regulation

Serialization: The First Steps In Sales Unit Traceability and Data Management

PAP-Q2-17-CL-002
CDMO

Supporting the Tech Transfer Continuum for Cell & Gene Therapies

PAP-Q2-17-CL-003
Regulatory

Moving Quality to the Forefront Brings Measurable Results

PAP-Q2-17-CL-008
Regulatory

The Mission of Commissioning Agents, Inc.

RJ Filannino, Manager of Technical Services, Mid-Atlantic, Commisioning Agents Inc. (CAI)

PTV-M03-17-IN-004
Regulatory

Advancing Clinical Trial Efficiency with Electronic Informed Consent

APR-M03-17-NI-001
Regulatory

Anticipating Future Guidelines By Utilizing The Latest Technologies In Particle Characterization

POP-M03-17-NI-001
Regulatory

What’s New in Bioanalysis?

Chad Briscoe, Executive Director, PRA Health Sciences

PTV-M11-16-AP-019
Continuous Processing

Continuous Processing

Stephen Sirabian, Executive Vice President, E/E Division, Glatt Air Techniques

PTV-M01-17-NS-002
Regulatory

FDA Issues Warning to Two More Companies

PAO-M03-17-NI-013
Regulatory

FDA, EMA Complete Mutual Recognition Journey

PAO-M03-17-NI-006

Q: How is the Need to Provide Local Drug-Product Supply in Multiple Regions Around the World Impacting Pharmaceutical Manufacturing Facility and Equipment Design?

PAP-Q1-17-RT-002
Excipients

Q: What will be the Impact of the Requirements that Drug Manufacturers Gain a Similar Level of Supply Chain Understanding for Excipients as they Must Have for APIs?

PAP-Q1-17-RT-005
Continuous Manufacturing

Advancing Solid Dose Processing Efficiency and Effectiveness

PAP-Q1-17-CL-008
Regulatory

Experience and Expertise Facilitate Controlled Substance Manufacturing

PAP-Q1-17-CL-004
Regulatory

AAPS Expedited Pathways

PAO-M11-16-NI-002
Automation

INNOVATION: Creating Solutions for Healthcare’s Ambitious Agenda

PAP-Q04-16-FA-001
CDMO

Q: What is Your Perception of the State of Serialization in Your Sector of the Pharma Industry?

PAP-Q04-16-RT-003
Clinical Trials

Perspectives on Product Pricing Strategy and Practice

PAP-Q04-16-NC-001
Process Development

Speed-to-Market: Process and Capacity on Demand

PAP-Q04-16-CL-014
CDMO

Q: What Are You Doing to Become a Premier Outsourcing Partner in the Context of FDA’s Recent Shift to a Focus on Quality Culture Rather than Just Metrics?

PAP-Q04-16-RT-002
CDMO

Achieving Successful Treatment Outcomes Through the Delivery of Manufacturing Services

PAP-Q04-16-CL-012
Supply Chain

Rx-360: An Industry Group Like No Other

PAP-Q04-16-CL-007
Outsourcing

Shaping the Conversation – Bringing Voice & Value

PAP-Q04-16-ED-001
CDMO

Process Performance Qualification Prep: a Strategic Approach Leads to Success

PAP-Q03-16-CL-008
Packaging

Track & Trace Systems for Serialization and Aggregation

PAP-Q03-16-CL-012
Excipients

What Are the Latest Guidelines for Excipients?

POP-M07-16-NI-001
EDC

The Pharmaceuticals App Market is Comparatively Weak and Inherently Limited, but Considerable Potential Exists

APR-M07-16-NI-001

Customer Experience: Key to Growth in the Outsourced Services Industry

PAP-Q1-16-IC-001

Continuous Processing: Meeting the Need for New Manufacturing Strategies

PAP-Q1-16-CL-005
Biologics

Will Biosimilars Make a Difference for the CMO/CDMO Market?

POP-M11-15-NI-001

What Does It Mean to be a Full-Service CDMO?

PAP-Q4-15-CL-002

In-depth Process and Product Expertise – This is Key to CDMO Support of Orphan Drug and Breakthrough Therapy Development & Commercialization

PAP-Q4-15-CL-004

Choosing the Optimal Drug Delivery System to Meet Patient Needs

PAP-Q4-15-CL-008
Excipients

Challenges Facing Pharmaceutical Excipients

APR-M05-15-NI-001
Regulatory

How a CMO Can Help With Investigational New Drug Applications

PAP-APR-S01-CL-002
Excipients

Speaking the Same Language – The Gap Between the Sales Pitch and Supplier Selection Criteria – And How It Applies in the Excipients Market

APR-M03-15-NI-004
Outsourcing

Biopharmaceutical Outsourcing To CROs In Emerging Markets Surges For 2015

LSL-M03-15-NI-002
Outsourcing

Selecting An Outsourcing Partner For Vaccine Production

ICO-M03-15-NI-001
Regulatory

What Does 2015 Hold For The Indian CMO Industry?

LSL-M03-15-NI-003
Clinical Trials

Logistics Providers Strive to Fulfill Biopharma Needs – Specialty Companies Offer Advantages, but Get a Bad Rap on Price

LSL-M11-14-NI-002
Outsourcing

Sponsors Not the Only Party to Benefit from Clinical Trials in Emerging Markets

POP-M06-14-NI-001
Drug Delivery

Pre-filled Syringe Technology Benefits Patients, Healthcare Providers and Drug Makers

CIO-M06-14-NI-001
CMO

2014 Trends in Strategic Outsourcing — Changes in the Qualities that Drive Outsourcing Partner Selection

CIO-M01-14-NI-001
CRO

What Can 2013 Outsourcing Trends Lead Us to Expect In 2014

LSL-M12-13-NI-001
CRO

The Top CROs by Therapeutic Indication Share Strong Regulatory and Productivity Performance

LSL-M09-13-NI-001
CRO

Outsourcing Clinical Research — Trends by Customer Group

LSL-M03-13-NI-001
Regulatory

How Relevant are 483s in Terms of Compliance Perception?

CIO-M11-12-NI-001
CMO

Will A Focus On Innovation Pay Off For Custom Synthesis Providers?

CIO-M08-12-NI-001
Outsourcing

Capacity Issues and the Question: To Insource or Outsource?

LSL-M08-12-NI-001
CRO

CROs & CMOs: Focusing On Innovation

LSL-M05-12-NI-001
Regulatory

Process Optimization: Innovation's Role

PPO-M04-12-NI-001
Outsourcing

Outsourcing to Emerging Markets: The Effect of the European Economic Crisis

PTO-M02-12-NI-001
CRO

Optimizing the Partner Selection Process for Drug Developers

LSL-M12-11-NI-002
CRO

Who Should Be Doing Your Pharmaceutical Analytical Testing — a CRO or CMO?

PPO-M12-11-NI-001
Clinical Trials

Where Do Strategic Business Opportunities Lie For Mid-Tier CROs?

PCO-M10-11-NI-001
CMO

Sterile Manufacturing Opportunities

PPO-M10-11-NI-001
Regulatory

Contract Services Spending: Who's Spending What, and Where?

BIO-M10-11-NI-001
Clinical Trials

Benefit From Clinical Trials In Emerging Markets While Limiting Risk Exposure

LSL-M09-11-NI-001
CDMO

Customer Drivers Influencing Supplier Differentiation

PTO-M08-11-NI-001
Regulatory

Do Companies That Offer Regulatory Support Services Score Higher On Regulatory Compliance?

LSL-M08-11-NI-001
Regulatory

Strong Regulatory Compliance and Reliability Indicative of Solid Partnership Choices

LSL-M06-11-NI-001
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