Standards & Regulation

Aug 03, 2015
By Pharmaceutical Technology Editors
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
Aug 03, 2015
By Pharmaceutical Technology Editors
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
Jul 29, 2015
The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.
Jul 28, 2015
By Pharmaceutical Technology Editors
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
Jul 27, 2015
By Pharmaceutical Technology Editors
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
Jul 27, 2015
By Pharmaceutical Technology Editors
Moses Lake Professional Pharmacy issues recall due to lack of sterility assurance.
Jul 24, 2015
By Pharmaceutical Technology Editors
The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
Jul 23, 2015
By Pharmaceutical Technology Editors
FDA warns an Arkansas compounding company that it is in violation of the FDCA.
Jul 21, 2015
A Federal circuit appeals court ruled that a biosimilar manufacturer must wait six months after FDA approval to commercially launch its medication.
Jul 17, 2015
By Pharmaceutical Technology Editors
FDA releases a report that analyzes why some diseases are lacking treatment options.