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 paper submissions 1 . The guidance, which follows ...

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 paper submissions 1 . The guidance, which follows ...

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 avoid securities suits 1 . Specifically, the case ...

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 which is the national Law on Guarantees and ...

Tamás Paál describes the country?s new unique regulatory procedure for officially authorising off-label prescriptions. In the European Union, off-label prescribing is not regulated by Community law. Having left the legal interpretation up to the ...

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 opprobrium for its role in the global financial crisis. In ...

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 certain political groupings in parliament 1 . ...

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 use of such measures in the area of medicines ...

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 was the consensus at the general meeting of the ...

Following extensive consultation with stakeholders, Health Canada has finalised a set of guidelines that reflect the authority?s new policy on reporting postapproval changes to drugs, biologics and radiopharmaceuticals 1 . The guidelines came into ...

The UK?s Medicines and Healthcare products Regulatory Agency has started applying a ?two strikes and out initiative? to leaflet variations submitted by parallel importers 1 . Under the initiative, parallel importers will be reminded by the MHRA only ...