Newsletter | October 26, 2023

10.26.23 -- 5 Best Practices For Responding To FDA Form 483 Inspection Observations

FEATURED EDITORIAL

4 Ways To Gain A Competitive Edge In This Biopharma Talent Shortage

It’s no secret that finding pharma/biotech manufacturing talent is challenging, and the lack of workers is having a negative impact on productivity and growth. Here are four effective strategies for recruiting, training, educating, and retaining your workforce.

Efficient Biotech Vendor Selection And Management During Economic Uncertainty

To navigate these turbulent economic waters effectively, we must view this funding crunch as a push for creativity and resiliency. This present moment requires a strategy integrating savvy financial management and strategic vendor selection to ensure a thriving biotech.

5 Best Practices For Responding To FDA Form 483 Inspection Observations

How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this five-step action plan to make sure the findings are properly addressed.

INDUSTRY INSIGHTS

Evaluation And Identification Of Subvisible Particulate Matter In Injections

Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

NEWS HEADLINES

Formycon Ranibizumab Biosimilar FYB201/Cimerli Achieved 25% Market Share In The U.S.

Samsung Bioepis Presents Phase 1 & 3 Clinical Results For SB16, A Proposed Biosimilar To Prolia (Denosumab), At ASBMR 2023

New Drug Channels Institute Study: U.S. Drug Distribution Industry Gaining From Anti-Obesity Drugs & Provider-Administered Biosimilars

Meitheal Pharmaceuticals Joins Biosimilars Forum

Sandoz Enters New Era As Stand-Alone Global Leader & European Champion In Generic & Biosimilar Medicines

PEI Announces Transition To Cost-Saving Biosimilar Medicines

Tyenne, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval

SOLUTIONS

Wearable Injector For Large-Volume And High-Viscosity Fixed-Dose Biologics

Downstream Digital Twins. Biopharma Going In Silico

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