Standards & Regulation - BioPharm International

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Standards & Regulation

FDA Talks Social Media

June 18, 2014

FDA issues guidance on the use of social media in regards to prescription drugs.

EDQM Releases 2013 Annual Report

June 18, 2014

EDQM details the agency?s accomplishments in 2013.

FDA Issues Guidance on Identifying Suspect Drugs

June 17, 2014

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

FDA Releases Draft Guidance on ANDA Submissions

June 12, 2014

Draft guidance from FDA includes information essential for the completion of ANDA applications.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

EMA Changes Guideline on Drug Name Acceptability

June 4, 2014

EMA publishes revised guideline on the acceptability of names for drugs.

FDA Creates Easy Access to FDA Public Data

June 3, 2014

FDA launches openFDA to provide easy access to FDA public data.

Global Expansion Shapes Drug Oversight

June 1, 2014

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Finished Product Monographs in the European Pharmacopoeia

June 1, 2014

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

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