American Pharmaceutical News In Review

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June 29, 2020

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Driving Data Integrity in the Right Direction

Data Integrity and Computerized System Validations (CSV) have become an area of increased scrutiny for regulatory agencies over the last several years. Understanding how the agencies view data integrity is critical for laboratories to maintain complete compliance. During this webinar, we investigated trends seen globally for data integrity violations and avenues for remediation. Watch now!

	Industry News

FDA Revokes Emergency Use Authorization for Chembio Antibody Test
The FDA has revoked the EUA of the Chembio DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, ... read more »

FDA Approves Pembrolizumab for TMB-H Solid Tumors
The FDA granted accelerated approval to pembrolizumab for the treatment of adult and pediatric ... read more »

Cosentyx Receives FDA Approval for New Indication
Novartis announced the FDA has approved Cosentyx for active non-radiographic axial spondyloarthritis... read more »

Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients
The FDA has approved a supplement to the Company's existing IDE for Hemopurifier in viral disease. read more »

Arch Biopartners to Proceed with Metablok Trial for COVID-19
Arch Biopartners announced the FDA has granted permission to proceed with a trial in the U.S. for ... read more »

FDA Approves First Treatment for Adult Onset Still’s Disease
The FDA approved Ilaris injection for the treatment of Active Still’s disease, including Adult-Onset... read more »

	Featured Articles

Data Integrity: 2020 FDA Data Integrity Observations in Review In 2020 thus far, numerous warning letters have been issued from the FDA citing data integrity ... read more »

An Interview With... Dr. Piet Christiaens, Scientific Director, Nelson Labs Europe When assessing the impact of extractables or leachables from a safety perspective, there are two ... read more »

	Featured Announcements

MycoplasmaMatters – Answers to Your Real-World Mycoplasma Testing Questions
Webinar
Regulatory requirements, lot release, in-process testing, risk mitigation, live mycoplasma ... read more »

	Infographic

Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take our 10-question quiz with your team to find out if you have the most efficient TOC monitoring program. read more »

	Featured Video

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

On-Demand Webinar: Making the Switch: The Evaluation, Implementation and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
In this webinar, you'll learn about Octapharma’s evaluation of the PCR method, as an alternative to the traditional growth-based mycoplasma testing ... watch »

	Featured Products

µDISS Profiler Small Volume Dissolution and Solubility Apparatus
read more »

Biopharm UNIFI System
read more »

	Featured Whitepaper

Hound blasts through your problems: ID inorganic and metal particles with LIBS
Hound can identify a wide range of contaminants including organic, inorganic, protein, and elemental particles using a combination of automated microscopy, Raman and LIBS. Learn how LIBS was used to ... read more »

Content Uniformity Measurement of an OTC Product Using a Dedicated Sample Preparation Station and a Fiber Optic UV Analysis System
Content uniformity (CU) is performed using a wide range of techniques for sample preparation and analysis. read more »

	Events

Sievers Eclipse BET Platform: A Closer Look at Efficiency Gains, Comparability, and Analytical Results
Online – 07/15/2020
In this webinar, attendees will receive an introduction to the groundbreaking Sievers Eclipse BET Platform to understand why it was created and how it... event details »

Wearable Injectors and Connected Devices Conference 2021
London, United Kingdom & Online – 10/18/2021
Innovations in on-body devices and connectivity to aid drug delivery and patient experience The global wearable devices market size is expected to... event details »

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