A small Cambridge, Mass. company is one of the first to provide solutions for Signatures and Authentication for Everyone (SAFE). SAFE is an industry effort to use software to manage the digital identities of employees. SAFE-BioPharma Association is a global identity management coalition founded by AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson… more...

European regulators will write simple versions of drug safety bulletins. In technical parlance, the EMEA says, summaries of European public assessment reports (EPARs) will be intended for ordinary patients. Each summary will have explanation of how the drug works, what ailments it should be used for, how it was studied,… more...

The FDA has issued a guidance on exploratory investigational new drug (IND) applications.  Such studies are defined as no more than a week long, “The Agency believes that sponsors have not taken full advantage of that flexibility and often provide more supporting information in INDs than is required by regulations.”… more...

Singapore’s TAKE Solutions, a provider of regulatory software, has provided an electronic labelling solution. “SubmitSPL” can help sponsors quickly meet structured product labelling (SPL) requirements. “TAKE solutions intends to bring process efficiencies to the critical path components of market application and market approval and launch of drugs, working closely with… more...