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Biologics, Proteins, Vaccines | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21
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Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs
Top BioPharma Form Accumulus Synergy
Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.Kristin Brooks 01.22.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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Breaking News | Drug Development | Promotions & Moves
Inozyme Pharma Appoints SVP, Regulatory Affairs
Dr. Kevin B. Johnson brings over 25 years of experience to the role.Contract Pharma Staff 11.09.20
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QA/QC | Regulatory Affairs
Regulatory Compliance Trends
Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.Steve Cottrell, President, Maetrics 10.14.20
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Breaking News | Promotions & Moves
Aphena Appoints Quality and Regulatory Affairs VP
Matthew Prokopczyk brings 25 years of experience in the pharmaceutical industry in the areas of quality control, regulatory compliance and quality assurance.Contract Pharma Staff 09.30.20
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Breaking News | Promotions & Moves
Aprecia Appoints Regulatory Affairs SVP
Kathi Rinesmith to oversee strategic regulatory affairs for the company's expanding pipeline of 3D-printed pharmaceuticals.Contract Pharma Staff 09.17.20
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Biologics, Proteins, Vaccines | Regulatory Affairs
Ensuring Manufacturing Continuity for Essential Medicines
Applying the principles of Quality Risk Management to get medicines to market faster.John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Managing Editor 09.09.20
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Aseptic Processing | Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Regulatory Affairs
LSNE Expands Aseptic Fill Finish Capabilities in Europe
LSNE-León receives approval from AEMPS to manufacture biotechnology-based therapeutic products.Contract Pharma Staff 08.28.20
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Biologics, Proteins, Vaccines | Breaking News | Promotions & Moves
Harpoon Therapeutics Appoints VP, Regulatory Affairs and Quality Assurance
Karin Ann Thacker brings 20 years of leadership experience.Contract Pharma Staff 08.27.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Online Exclusives Kristin Brooks, Contract Pharma 08.25.20
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Drug Delivery | Regulatory Affairs
Regulatory Overhaul for Medical Devices
Implications for the pharmaceutical industry.Elizma Parry, Director, Global Clinical Practice, Maetrics 06.04.20
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Information Technology | Regulatory Affairs
Data Integrity: Beyond Electronic Records
Get your Data Integrity house in orderTim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20
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Industry News | Regulatory Affairs
FDA COVID-19 Update
Issues guidance highlighting flexibility under the Drug Supply Chain Security ActContract Pharma Staff 05.01.20
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Industry News
Diamond Pharma Services Acquires PharmaCentral
Strengthens pharmacovigilance division and expands presence in EuropeContract Pharma Staff 04.22.20
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cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs
FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20
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Drug Development | GMPs/GCPs | Regulatory Affairs
FDA’s Emergency Use Authorizations
Aggressive Action Taken to Combat COVID-19Chad Landmon and Drew Hillier, Axinn, Veltrop & Harkrider LLP 04.20.20
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Promotions & Moves
ISPE Appoints European Regulatory Advisor
Duliere brings more than 20 years of experience in the pharmaceutical manufacturing industry04.02.20
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Regulatory Affairs
Inquiring Minds Want to Know, Just Ask FDA
What you need to know prior to submissionMichelle Ryder, Lachman Consultant 04.01.20
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Breaking News | Promotions & Moves
Q BioMed Appoints Head of Global Regulatory Affairs
Geoff Fatzinger will lead the global regulatory approval strategy for the commercialization of FDA approved, non-opioid Strontium89.03.31.20
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Breaking News | Industry News | Packaging & Tracking | Regulatory Affairs | Solid Dosage/Semi-solids
Novartis Recalls Sandimmune, Neoral Blister Packs Due to Packaging Failure
Corrective action plan to address blister packs that do not meet U.S. child-resistant packaging requirements, there are no quality or efficacy issues.03.19.20
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Breaking News | Industry News | Inspections | Regulatory Affairs
COVID-19 Update: FDA Scales Back Domestic Inspections
Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.03.19.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
COVID-19 Update: FDA Foreign Inspections
To postpone most foreign inspections through April, effective immediately03.10.20
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Breaking News | Promotions & Moves
AMAG Pharma Makes Organization Changes
Executive Vice President and Chief Medical Officer, Julie Krop to leave the company03.04.20
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Regulatory Affairs
The Art of Filing NDA/ANDA Post-Approval Changes to the FDA
Some tips to make your trip along the regulatory pathway to report manufacturing changes easier.Amy Schutte, Senior Associate, Lachman Consultant Services 03.04.20
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Breaking News
Transcenta Achieves Major Milestone in Perfusion Cell Culture Platform
It will provide industry leading productivity and speed to manufacturing.02.28.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
FDA Provides Update on Activities Related to Coronavirus
Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world02.25.20
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Breaking News | Industry News | Promotions & Moves
Vectura Expands Executive Leadership Team
Appoints Sharon Johnson as executive vice president for delivery management02.10.20
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Breaking News | Promotions & Moves
BryoLogyx Appoints Clinical Development, Logistics VP
Crockford brings extensive pharmaceutical development experience02.03.20
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Capacity Management Within Functional Service Partnerships
Looking at the advantages and disadvantages of moving capacity management from sponsors to their FSP vendors.Brian Ford and Timothy King, PPD FSP 01.28.20
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Bio News | Breaking News | Facilities | Regulatory Affairs
PathoQuest Facility Gets GLP Certified
First company in France to receive GLP Certificate from the ANSM01.27.20
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Breaking News | Industry News | Regulatory Affairs
Dalton Expands Cannabinoids Capabilities
Receives license amendment from Health Canada Cannabis Regulation approving sale of cGMP cannabis derived products to License Holders.01.15.20
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Breaking News | Clinical Trials | CRO News | Drug Development | Regulatory Affairs
Parexel Launches Regulatory & Access Consulting Organization
Alignment of these capabilities aims to save time and resources across the drug development lifecycle01.10.20
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Promotions & Moves
Altasciences Appoints Senior Director Compliance and RA
Paul will lead the development of the company’s regulatory offering, from preclinical to clinical research, for all services01.10.20
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Bio News | Breaking News | CRO News | Drug Development | Industry News
PPD Expanding Capabilities in China
Enhancing drug development for international pharma companies and Chinese biotechs.01.09.20
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Breaking News | Promotions & Moves
CARsgen Therapeutics Appoints Global Regulatory Affairs SVP
Dr. Fan will be responsible for CARsgen global regulatory strategy, leading the U.S. and China regulatory affairs team01.06.20
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Planning for Commercial Success
Best Practices for Designing Cell & Gene Therapy Clinical TrailsVideos
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Breaking News | Promotions & Moves | Regulatory Affairs
PhRMA Appoints Federal Advocacy SVP
Anne Esposito to oversee the association's federal government affairs12.06.19
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Breaking News | Industry News
CPhI’s 16th Pharma Awards Winners
Dr. Ge Li wins ‘CEO of the Year’ and John Chiminski a ‘Lifetime Achievement’ award.11.13.19
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Breaking News | Industry News | Regulatory Affairs | Solid Dosage/Creams/Ointments
Absorption Systems Awarded Contract by FDA
To conduct in vitro testing of the effects of excipients on oral drug absorption.11.01.19
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Breaking News | Industry News | Regulatory Affairs
FDA Leaders Address Drug Shortages
Acting Commish Ned Sharpless and CDER director Janet Woodcock release statement on FDA's new report about root causes and solutions to drug shortages.10.30.19
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Finalists Revealed for CPhI Worldwide’s 2019 Awards
Formulation and packaging categories were the most competitive.Online Exclusives10.29.19
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Analytical Services | GMPs/GCPs | Regulatory Affairs | Toxicology
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Regulatory Affairs
Inactive Ingredients: Where Guidance Needs to Meet Data
Looking at FDA’s most recent draft guidance and the struggle with inactive ingredients.Sharif Ahmed, Lachman Consultants Services 10.15.19
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cGMP Manufacture
Deriving Value from Integrated cGMP and Pre-GMP Manufacturing Operations
The benefits of leveraging a mix of GMP and pre-GMP facilities.Didier Combis, Commercial Director, Seqens CDMO 10.15.19
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Clinical Trials | CRO News | Drug Development
NSF International Acquires Interest in Amarex CRO
Amarex will gain access to NSF’s network and international scale and will continue to operate from its U.S. office10.09.19
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Regulatory Affairs | Serialization
Fighting Back!
The drug industry takes a bare-knuckle approach to drug counterfeiters.Daniela Geiger, Vetter 10.04.19
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Breaking News | Industry News | Regulatory Affairs
LSNE's Spain Site Gets FDA Approval
LSNE-León is the fourth facility to gain commercial approval10.04.19
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Breaking News | Industry News | Inspections | Regulatory Affairs
Almac Completes Three Regulatory Inspections
Inspections at Charnwood, Craigavon, and Audubon sites successful09.27.19
