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...
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.
The US Food and Drug Administration (FDA) has adopted a practical Q&A from the International Conference on Harmonisation (ICH) to help sponsors and CROs craft clinical study reports (CSRs), an expert says.
Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.
Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
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.
As vaccine production in India has hit manufacturing roadblocks over the past few years, GlaxoSmithKline (GSK) has signed a joint venture to begin development of a six-in-one pediatric vaccine.
Covance management sounded relatively upbeat about its expectations for 2013 as late-stage clinical trials continue to grow and IT spending begins to taper off, company officials said on Friday.
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...
AmerisourceBergen has announced upbeat Q1 results as contributions from Consulting Services and World Courier offsets ongoing cost issues in Drug Distribution.
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 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.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
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.
Janssen says an alternative manufacturing approach will restore Doxil supplies, days after Ben Venue Laboratories’ (BVL) entered into consent decree with FDA.
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...
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Parexel, AmerisourceBergen and Norwich Pharmaceuticals.
Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.
‘Unfair competition’ from Asian drugmakers and the prevalence of counterfeits are among the challenges facing African manufacturers according to a new pan-African industry group set on fostering local production.
The UK's cell therapy industry now has a database of all ongoing clinical trials in the country with the aim of expanding research partnerships and pushing more early-stage trials to later stages.
GlaxoSmithKline has decided to only make once-monthly payments to suppliers, which could increase the amount of time it takes a CRO, CMO or other supplier to be paid for its work.
Covance says its agreement with the Royal Liverpool and Broadgreen University Hospitals NHS Trust will improve drug development and bring drugs to market sooner.
Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.
The cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.
Almac says the completion of a Knowledge Transfer Partnership (KTP) has aided biocatalysis development offering clients an array of streamlined processes.
The Singapore Economic Development Board (SEDB) says it wants to nurture industry, academic and institutional alliances to attract further global investment in ‘Asia’s fastest growing bio-cluster.’
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.
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.
Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
ADC Biotechnology has secured funding to take its cost-cutting antibody drug conjugate (ADC) tech to market and says pharma demand will drive partnerships and maybe even attract CMO takeover bids.
Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
German chemicals giant BASF expects its revised takeover bid for Norwegian omega-3 API manufacturer Pronova Biopharma ASA to be accepted by resistant shareholders.
Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
The UK government’s health committee is calling for all clinical trial information to be in the public domain but industry push back is expected, experts say.
Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.