New drug development process FDA // Drug Repurposing

New drug development process FDA

Therapeutic Development

Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells us that “a good name is better than precious ointment.” In a new draft guidance applicable to Rx and OTC products, FDA has laid out a detailed system to assist sponsors in selecting precious proprietary names that will pass FDA review. The system includes four chronological steps: (1) a prescreening process to weed out things like obvious similarities in pronunciation or spelling; (2) a secondary review to detect misleading and error-prone attributes such as inclusion of the product dosing interval (e.g., “BID”); (3) a misbranding review to determine whether the proposed name suggests safety, efficacy or other unique attributes that are not supported by scientific evidence (e.g., including “best” in a name); and (4) a final look-alike sound alike (“LASA”) safety review that utilizes searches of public databases and extensive name simulation studies designed to mimic multiple real world use scenarios of the proposed product.

The primary motivation for the new guidance is patient safety, with reduction of inappropriate promotional claims a secondary interest. FDA states that the draft guidance partially fulfills its PDUFA IV commitment to take steps to reduce medication errors and cites a 1999 Institute of Medicine report that attributed 7, 000 annual US deaths to such errors. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Institute of Medicine, National Academies Press: Washington, DC, 2000. The new draft guidance partially reflects input from public meetings held in June and December of 2003 and July of 2008 and an FDA pilot program (see our previous posts here and here) and is intended to complement the existing guidance entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.”

You might also like

Drug Development and FDA Regulations Trailer
Drug Development and FDA Regulations Trailer
Dr.Gulati on New Drug Development Process
Dr.Gulati on New Drug Development Process

Oh yea, there's an unbiased site

by OmniscientlyMe

*rolls eyes*
but there are some things that support what i'm saying.
'Every year, thousands of new cosmetic, personal care and household products are introduced into the marketplace. Virtually all of them have been animal-tested at various stages of their development. Long before they appear on the shelves of your local supermarket, these products have gone through a long and complex testing process that leaves millions of animals mutilated, burned, poisoned and gassed in outmoded and unnecessary tests.'
i also found it laughable that the alternative tests mentioned still included large numbers of animal parts and even embryos

Inform Genomics and Translational Drug Development (TD2) Announce ..  — MarketWatch
.. LLC (TD2) based in Scottsdale, Arizona, today announced a strategic collaboration leveraging Inform Genomics' proprietary technology platform and analytic capabilities to biopharmaceutical companies through TD2's oncology drug development services.

University of Michigan Library Methods of development of new anticancer drugs: U.S.A.-U.S.S.R. monograph
Book (University of Michigan Library)