Newsletter | February 17, 2022

02.17.22 -- FDA Releases Real-World Evidence Draft Guidance

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Featured Editorial

FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug And Biological Products
		By Bethany Hills and Daniel Rubin, Morrison & Foerster The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.

Plot A Successful Course: Critical Risk Assessments With CDMOs
		By Amanda McFarland, ValSource, Inc. The landscape of risk management between biopharma companies and their CDMOs looks nothing like those where direct oversight is the operating paradigm. This article shares recommendations on how to find common ground when assessing risks as well as tips to facilitate trust.

Industry Insights

Addressing The Evolving Needs Of Variable Drug Delivery Regimens

White Paper | By Temitope Sodunke, Ph.D., BD Medical - Pharmaceutical Systems

Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and for customization to support adjustments to existing formulations and variations in treatment regimens.

Purifying Infectious Virus Particles Using ÄKTA™ Start

Application Note | Cytiva

This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using a benchtop chromatography system, HiTrap brand columns, and Capto brand Core 700 resin.

Tech Transfer In Sterile Injectables: 3 Phases Of Success

Webinar | Pfizer CentreOne

Explore the three phases of sterile injectable project tech transfer, including how to bridge information gaps and facilitate successful regulatory filing at this fundamental stage of drug development.

News Headlines

• Cardinal Health Predicts 2022 To Be Turning Point For Biosimilars In The U.S.

• Biogen And Xbrane Announce Commercialization And License Agreement For Proposed Biosimilar Referencing CIMZIA® (Certolizumab pegol) With The Potential To Treat Rheumatoid Arthritis

• Launch Of Generium’s Omalizumab Biosimilar For Atopic Bronchial Asthma Marks Selexis’ Ninth Commercial Product

Solutions

Accelerating Product Development With Intelligent Collaboration

Pfizer CentreOne

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