India finds 5.5% of drugs substandard; New bill aims to speed FDA approvals;

> Questions in the Indian parliament as to whether Indian regulators have a handle on substandard and counterfeit pharmaceuticals being made there prompted a minister to report that in the first half of 2011, 5.5% of the 26,000 drugs tested were substandard. Story

> The FDA has filed a document with the Federal Register reiterating its estimate that electronic registration of drug manufacturers and their products, and the additional information sought, should add an average burden of only 4½ hours to the process. It will accept comments, made by fax, until April 25. Filing

> Creating a new wrinkle for cosmetics manufacturers, the director of the FDA's Center for Food Safety and Applied Nutrition told a House subcommittee that so-called "cosmeceuticals" that contain active ingredients like retinol may need to be regulated like drugs. Story

> Members from both parties in Congress have filed a new bill that would speed FDA approvals, this time for so-called breakthrough drugs, any drug aimed at serious conditions or diseases where preliminary clinical trials indicate a substantial improvement over existing therapies. Story

> Novasep says it is opening a 2,000 square meter facility in Shanghai to expand production of its purification technologies and integrated processes in batch and continuous membrane filtration, ion exchange and chromatography. Story


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.