Regulatory Affairs

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

Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs

COVID-19 Update: FDA Foreign Inspections

To postpone most foreign inspections through April, effective immediately

03.10.20

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

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 world

02.25.20

Bio News | Breaking News | Facilities | Regulatory Affairs

PathoQuest Facility Gets GLP Certified

First company in France to receive GLP Certificate from the ANSM

01.27.20

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

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 lifecycle

01.10.20

Breaking News | Promotions & Moves | Regulatory Affairs

PhRMA Appoints Federal Advocacy SVP

Anne Esposito to oversee the association's federal government affairs

12.06.19

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

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

Analytical Services | GMPs/GCPs | Regulatory Affairs | Toxicology