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American Pharmaceutical News In Review
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June 12, 2020
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  4 Signs You Need to Talk to a Pharma QA/QC Compliance Service Provider

Pharmaceutical organizations need stringent quality assurance and quality control programs to ensure compliance at all times and avoid the harsh penalties that come with failure to follow regulations. In the last fiscal year, the U.S. Food and Drug Administration Office of Manufacturing Quality issued 81 warning letters to manufacturers of finished medicinal products. Solely handling QA/QC processes internally, however, is not always the correct approach. Read about four key signs that you need to talk to a QA/QC service specialist.

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» Industry News
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  FSD Receives FDA Approval to Design Trial for COVID-19 Treatment
FSD announced the FDA has given the company permission to submit an IND for the use of FSD-201 to ... read more »
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  RenovoRx Announces Orphan Drug Designation Granted for Treating Bile Duct Cancer
RenovoRx announced the FDA has granted the Company orphan drug designation for treating bile duct ... read more »
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  GenScript Files for EUA of Rapid SARS-CoV-2 Neutralization Antibody Detection Kit
GenScript Biotech announced the company has filed for EUA with the FDA to market its cPass™ SARS-CoV... read more »
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  Amneal Issues Recall of Metformin Hydrochloride Extended Release Tablets
Amneal is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, ... read more »
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  AbbVie Submits Regulatory Applications to FDA, EMA for Psoriatic Arthritis Treatment
AbbVie has submitted applications for a new indication to the FDA and EMA for RINVOQ for adult ... read more »
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  Vizuri Health Sciences Reorganizes into Two Separate Companies
Vizuri Health Sciences has completed a reorganization to form two new corporations. read more »

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» Featured Articles
QC Corner: Improved Pharmaceutical Quality Control through Updated Monograph Methods
Monographs and general chapters that provide public quality standards for drugs, excipients, and ... read more »
An Interview with... Russ Miller Director, Business Development, Vectura
Drug development in general is in a strong phase, with FDA approval numbers also being very healthy.... read more »
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» Featured Infographic
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  Essential Features for Choosing Your Sterility Testing Equipment
Essential Features for Choosing Your Sterility Testing Equipment
Sterility testing is a crucial step in pharmaceutical product release. read more »
» Featured Video
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  Making Data Work Leveraging Data for Better Outcomes
Data collection has been a common practice for years in the pharmaceutical industry. But with the explosion of devices and technologies to acquire ... watch »
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  In Vitro Test Methodologies for Characterizing Bioavailability Enhancing Formulations
This webinar discusses several in vitro methodologies used at Lonza for the characterization of bioavailability enhancing formulations as well as ... watch »

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» Featured Products
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  Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
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  APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
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» Featured Whitepaper
R&D to Product: How to reduce costly scale-up problems
When scaling a new drug formuation. read more »
From LAL to rFC Assays: A more sustainable future for endotoxin testing
Bacterial endotoxins are pyrogenic lipopolysaccharides found in the outer cell membrane of Gram-negative bacteria. Ubiquitous in the environment, endotoxins can easily enter the patient’s bloodstream ... read more »

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| Events
EVENT
  HPLC 2020, the 50th International Symposium and Exhibit on High Performance Liquid Phase Separations and Related Techniques
San Diego, CA –  06/20/2020
SHAPING THE FUTURE OF SEPARATION SCIENCE The HPLC conference will celebrate its 50th edition in beautiful San Diego, an exciting biotech hub along ...
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EVENT
  Microscopy & Microanalysis 2020
Online –  08/02/2020
We are excited to announce that the M&M 2020 Meeting content will be presented on a virtual (completely online) meeting in its place. MSA/MAS member ...
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