For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.
As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
The counterfeiting of over-the-counter drugs is a growing problem according to an ex-criminal prosecutor, but the nature of such medicines means the problem often goes unreported.
As part of an effort to provide more certainty, India’s CDSCO (Central Drugs Standards Control Organization) has offered up a new compensation formula for trial participants who are killed or injured during a trial.
As the European Medicines Agency (EMA) has implemented the majority of elements of the new pharmacovigilance legislation, the agency is now reporting that the main objectives of the legislation are largely being achieved.
Hospira says approval for its new manufacturing facility in India is still on track despite receiving a Form 483 form the US FDA with ten observations.
The European Medicines Agency (EMA) has published guidance for departing employees intended to ensure there is no conflict of interest in their new roles.
The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.
Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.
Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.
Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.
Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.
Roche has clashed with the authors of a report slamming the efficacy of Tamiflu, each claiming the other’s analysis of patient data is seriously flawed.
Tamiflu shortens the duration of influenza symptoms by only half a day, does not stop person-to-person spread and increases the risk of nausea say the authors of a new review who want Governments to rethink stockpiling neuraminidase inhibitors.
The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.
Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or...
Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.
GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.
The pharmaceutical industry lacks the regulatory models to govern sweeping changes in the near future surrounding combination products and large molecule drugs, said an expert at DIA Euromeeting in Vienna last week.
Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.
Hospira has agreed to pay $60m (€44m) to settle a lawsuit related to manufacturing and quality control deficiencies at its Rocky Mount facility, which is already subject to a $200m remediation programme.
The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
Shire has recalled one batch of its Gaucher’s disease drug VPRIV in the US after problems at its fill finish contractor resulted in particulate matter ending up in the vials.
New EU laws safeguarding national ownership of ‘genetic resources’ may delay production of seasonal influenza vaccines according to EFPIA, which wants stakeholders to discuss the issue.
Australia may lose its status as the leading supplier of pharma grade opium if it does not comply with Big Pharma requests and allow cultivation of the crop on the mainland.
As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine.
Sun Pharma’s antibiotic facility import alert is the latest blow to the Indian drug industry but is unlikely to impact revenues or cause US shortages, the firm says.
The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.
Access to mixed hydrocodone painkillers such as AbbVie’s Vicodin will be restricted and production limited if plans by the US Drug Enforcement Administation (DEA) are cemented later this year.
Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
Publication of a US FDA enforcement report detailing a recall by Ranbaxy in January saw the beleaguered Indian drugmakers’ share price fall 3% last week.
