Regulatory Beat - BioPharm International


Regulatory Beat

Quality by Design Bridging the Gap between Concept and Implementation

April 1, 2014

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

April 1, 2014

New identifiers and tracking requirements aim to block illegitimate products.

European Union Packaging Safety Features Come into Effect

March 1, 2014

Manufacturers are taking measures to comply with new package safety rules.

EMA Collaborates with HTA Assessment Networks

February 1, 2014

High technology assessments are having an impact on biosimilars development in Europe.

Opioid Regulation Challenges FDA and Manufacturers

December 1, 2013

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Congress Revises Rules for Drug Compounding and Supply-Chain Security

November 1, 2013

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

FDA Seeks Metrics to Define Drug Quality

October 1, 2013

Manufacturing standards are considered key to preventing drug recalls and shortages.

Regulatory Roundup

September 1, 2013

Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.

EU Raises API Standards: A Curse in Disguise?

September 1, 2013

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?



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