Regulatory Affairs

Inspections | QA/QC | Regulatory Affairs

FDA Inspection Trends Update

Insulate yourself from risk to achieve success in your FDA inspections.

Ben Locwin, Contributing Writer 05.02.22

Biologics, Proteins, Vaccines | Regulatory Affairs

Phase-Appropriate cGMP Considerations for Cell and Gene Therapy

Readiness to begin GMP manufacturing is a decision point that requires careful consideration.

Keith Lamb, Executive Director, Lachman Consultants 05.02.22

Clinical Trials | QA/QC | Regulatory Affairs

Conducting Clinical Trials During the Pandemic: What Did We Learn?

Key takeaways from MHRA's Good Clinical Practice Symposium.

David S. O’Connor, Senior Director, Lachman Consultants 04.08.22

Regulatory Affairs

Improving Public Health

Regulatory considerations around bioequivalence in topical generic drug product development.

John Buchan, Life Science Technology Specialist 02.01.22

Regulatory Affairs

The Future of Pharma

Robert Califf’s appointment to head of FDA is a signal of the future of pharma.

Ben Locwin, Contributing Editor 02.01.22

Biologics, Proteins, Vaccines | cGMP Manufacture | Regulatory Affairs

Pharma Outlook 2022

CPhI report says high manufacturing demand to constrain global ingredients, partnering options and available CDMO capacity.

01.14.22

Ardena Expands Capacity to Satisfy Novavax COVID Vaccine Demand

Site in Södertälje, Sweden will see capacity increases in purification and fractionation of GMP manufacturing.

01.13.22

WuXi STA, Coherent Biopharma Enter Strategic PDC Pact

WuXi STA to provide peptide platform services from drug discovery to commercial manufacturing to support Coherent’s PDC drug candidate development.

12.01.21

Clinical Trials | Drug Development | QA/QC | Regulatory Affairs

Pharmacovigilance: Improving Public Health

A look into modern pharmacovigilance, regulatory role in drug safety, and public health and ADR reporting.

John Buchan, pharmasol 11.23.21

Demystifying Pharma Packaging Regulations Now and in the Future

Watch the on-demand webinar.

Sponsored released by ACG Group 10.11.21

Breaking News | Facilities | Industry News | Regulatory Affairs

Sterling Pharma Solutions Recognized for Achievements in Sustainability

Awarded Gold Medal by EcoVadis.

09.03.21

FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

Grants first full approval for COVID vaccine.

08.23.21

Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain

United States Pharmacopeia Acquires Pharmatech Associates

Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.

07.09.21

Information Technology | QA/QC | Regulatory Affairs

The Importance of Data Integrity Risk Assessment

Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

Paul Mason, Ph.D., Lachman Consultants 06.07.21

Regulatory Affairs

Meeting with the FDA: Valuing the Statistician and Preparation for Review

A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.

Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21

Biologics, Proteins, Vaccines | Regulatory Affairs

What Will Change at FDA for 2021?

(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21

Regulatory Affairs

Post-Pandemic Regulations

Envisioning clinical development regulatory practices in a post-pandemic world.

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 04.01.21

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

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

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