Regulatory Affairs

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

APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs

Regis Custom Pharma

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Deanna Rentner, Marketing Coordinator 11.12.20

QA/QC | Regulatory Affairs

Regulatory Compliance Trends

Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.

Steve Cottrell, President, Maetrics 10.14.20

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

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

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

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

Drug Delivery | Regulatory Affairs

Regulatory Overhaul for Medical Devices

Implications for the pharmaceutical industry.

Elizma Parry, Director, Global Clinical Practice, Maetrics 06.04.20

Information Technology | Regulatory Affairs

Data Integrity: Beyond Electronic Records

Get your Data Integrity house in order

Tim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20

Industry News | Regulatory Affairs

FDA COVID-19 Update

Issues guidance highlighting flexibility under the Drug Supply Chain Security Act

Contract Pharma Staff 05.01.20

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

Drug Development | GMPs/GCPs | Regulatory Affairs

FDA’s Emergency Use Authorizations

Aggressive Action Taken to Combat COVID-19

Chad Landmon and Drew Hillier, Axinn, Veltrop & Harkrider LLP 04.20.20

Regulatory Affairs

Inquiring Minds Want to Know, Just Ask FDA

What you need to know prior to submission

Michelle Ryder, Lachman Consultant 04.01.20

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

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