The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for the proposed trial.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Dendreon, Shire and Targacept.
Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.
An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.
A new personalised medicine-focused partnership for AstraZeneca, expansion in three continents for World Wide clinical and six small CROs team-up to create one super-team. Outsourcing-pharma.com presents a round-up of the latest in clinical research services.
in-PharmaTechnologist.com presents its weekly round-up of the latest new appoitnments within the world of pharma and biopharma including news from J&J, Teva and Amarantus.
Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from Chiltern, Thermo Fisher and Penn Pharma.
Barack Obama’s re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry.
in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Watson, OvaScience and Sirona.
Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.
New Zealand regulator Medsafe and the Taiwan FDA will join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) next year.
Pharmaceutical firms should let the EMA know about minor variations to marketing authorisation (MA) by the end of next month if they want to avoid delays over the festive period.
All parties involved in the distribution of biologics in India must take responsibility for quality and keep seasonal temperature variations in mind says the CDSCO.
The UK Intellectual Property Office (IPO) wants to make it easier to develop drugs in the country by changing the rules relating to patent infringement in clinical trials.
in-PharmaTechnologist.com presents its weekly round-up of career changes in the pharmaceutical industry, including news from Heptares, Cerecor and Dyax Corp.
Watson and acquisition target Actavis must sell 18 drugs to rivals Sandoz and Par Pharma under conditions imposed by the US Federal Trade Commission (FTC).
Outsourcing-Pharma.com presents its weekly round-up of the latest changes, faces and places in the pharma services sector, including news from Wolters, Advanced Clinical and BIA.
Manufacturers trying to prove the similarity of their biosimilars must consider that regulations and reference medicines differ in different markets says Pfizer.
Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information.
in-PharmaTechnologist.com presents its weekly round up of the latest movers and shakers in the world of pharmaceuticals, including news from Cytos, Ablynx and Baxter.
