All news articles for January 2013

EMA Offers Inside Look at Clinical Trial Inspections

EMA Offers Inside Look at Clinical Trial Inspections

By Zachary Brennan

Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a drug.

Lonza may move away from manufacturing

Lonza hints at manufacturing cuts

By Dan Stanton

Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.

FDA Warns Taiwanese Drug Manufacturer Over GMP Violations

FDA Warns Taiwanese Drug Manufacturer Over GMP Violations

By Zachary Brennan

As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter to Taiwanese manufacturer Beanne Chemical may serve as an example...

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

By Zachary Brennan

The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.

FDA Finalizes cGMP Rule for Drug-Device Combo Makers

FDA Finalizes cGMP Rule for Drug-Device Combo Makers

By Zachary Brennan

The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its proposed rule from 2009.

EU to Further Align GMP, Process Validation Standards with ICH, FDA

EU to Further Align GMP, Process Validation Standards with ICH, FDA

By Zachary Brennan

The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes related to its process validation and good manufacturing...

US seeks exemption from new EU API import laws

update

US asks for exemption from EU API import laws

By Gareth Macdonald

The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.