The US Food and Drug Administration has issued guidance explaining how and why manufacturers of biological products should submit their lot distribution reports (LDRs) electronically rather than as...
India's department of industrial policy and promotion (DIPP) has put out a "discussion paper" on the controversial subject of compulsory licences, aimed at developing a "predictable environment" for...
The US Supreme Court has agreed to review Matrixx Initiatives Inc v Siracusano, a case that has the potential to determine which adverse event reports a drug maker must disclose to shareholders to...
Problems relating to the mechanism in which manufacturers supply drugs to wholesalers in the UK are resulting in many patients still not receiving the medicines they need when they need them. This...
The US Food and Drug Administration’s paediatric advisory committee will meet on 21 June to discuss paediatric-focused safety reviews for 13 drugs, including four proton pump inhibitors 1 . The four...
The European Ombudsman has asked the European Medicines Agency to review its transparency policy so that the public may have access to suspected serious drug adverse reaction reports, regardless of...
Trust and respect seem to be in short supply these days, at least where certain sectors of society are concerned. At international level, the banking industry is under a dark cloud of public...
The MEP responsible for guiding the controversial patient information proposal through the European Parliament says he is not prepared to see it derailed by opposition from member state ministers and...
Spain has transposed into national law European Union Directive 2006/123/EC on free access to services in the internal market 1 . The new “omnibus law” 2 updates a total of 47 national laws, one of...
The British government has announced plans for a new “life sciences super cluster” to boost translational research and to help deliver the next generation of medicines and technologies needed to...
The Spanish Medicines and Healthcare Products Agency ( AEMPS ) has taken additional steps under its initiative to increase the transparency of and accessibility to information for healthcare...
The US Food and Drug Administration has conceded that its oversight of postmarketing studies for drugs cleared under the accelerated approval process has been inadequate in the past. But the agency...
The Philippines Food and Drug Administration has launched a new hotline to allow consumers to report any complaints they have about drugs being sold in the country 1 . Consumers can report problems...
The Irish Medicines Board is planning to change its parallel import scheme following a review that highlighted noncompliance issues, recalls and lack of traceability of medicinal products covered by...
A progress report released jointly by the European Commission , the European Medicines Agency and the US Food and Drug Administration on last year’s “Transatlantic Administrative Simplification...
