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May 07, 2021

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Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation-Body

The requirements for assessing irritation is now moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing.

	Industry News

Amphastar Pharmaceuticals Receives FDA Approval for Morphine Sulfate Injection
Amphastar Pharmaceuticals announced that the U.S. FDA approved the company’s Abbreviated New Drug ... read more »

FDA Approves Emergency Treatment for Opioid Overdose
The U.S. Food and Drug Administration has announced the approval of a higher dose naloxone ... read more »

Sandoz Confirms Late-Stage Clinical Development Plans for Proposed Biosimilar Aflibercept, a Key Ophthalmology Medicine
Sandoz, a Novartis division, has announced progress in the late-stage clinical development program ... read more »

	Infographic

Levels of Disinfectant Claims When Marketing a New Disinfectant
Whether you have an existing disinfectant or are looking to launch a new product into the market, the EPA requires several testing criteria to be met ... read more »

	Featured Articles

Sampling, Process Sensors, and Data Packages that are Incorporated into PAT/QbD for Continuous Manufacturing COVID-19 has changed the world like nothing most of us have ever experienced in our lifetime. The world is dealing with a greater number of critical ... read more »

Base Editing: A New Player in the Cell and Gene Therapy Space Last December, Vertex Pharmaceuticals and CRISPR Therapeutics shared initial clinical trial data from studies on CTX001, a cell-based therapy for ... read more »

	Featured Video

On-Demand Webinar: Sustainability In Bacterial Endotoxin Testing – A Holistic Approach – Part II
In this webinar you’ll learn new developments in recombinant technologies, updates on the regulatory framework around recombinant reagents, sharing ... watch »

On-Demand Webinar: Implementation of the SoloVPE Technology for Protein Concentration Measurement of Monoclonal Antibodies
In this webinar you’ll learn: the benefits of implementing the SoloVPE® technology for protein concentration analysis in a Quality Control laboratory;... watch »

On-Demand Webinar: Development Strategies for Expediting Time-to-Market of Spray Dried Amorphous Solid Dispersions
Key learning objectives in this webinar are linking process parameters to critical quality attributes and how to address them during development, ... watch »

	Featured Whitepaper

White Paper: Validation of a Duplex qPCR Assay to Detect Residual Sf9 Host Cell DNA and Baculovirus DNA
Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important to have a sensitive method of quantifying ... read more »

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