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 hints at manufacturing cuts

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Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs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 asks for exemption from 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.

Freeman signs Canadian distribution deal

Freeman signs up Canadian distributor

By Gareth Macdonald

Freeman Technologies has signed a Canadian distribution deal for its powder flow analysis tech in a bid to win more QbD and PAT-focused Pharma customers.

India's Top Court Takes Control as Trial Regulations in Flux

India's Top Court Takes Control as Trial Regulations in Flux

By Zachary Brennan

Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme Court order seeking answers on their alleged lax oversight of trials.

Software Offers Sponsors, CROs Improvements to On-Site Monitoring

Software Offers Sponsors, CROs Improvements to On-Site Monitoring

By Zachary Brennan

Following the release of FDA and EMA guidance in 2011 calling for CROs and trial sponsors to take a more risk-based approach to monitoring trials, companies have begun offering products to improve source data verification and more efficiently monitor their...

Impax remains upbeat after FDA rejection

Impax remains upbeat after NDA rejection

By Dan Stanton

Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.

EC Updates Guidance to Ensure Supplier Compliance

EC Updates Guidance to Ensure Supplier Compliance

By Zachary Brennan

The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

EU Agrees to Joint GMP Audits with Israel, New Zealand

EU Agrees to Joint GMP Audits with Israel, New Zealand

By Zachary Brennan

The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.