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1244 items
3:58 PM, Sep 14, 2018  |  BioCentury | Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...
6:40 PM, Aug 17, 2018  |  BioCentury | Regulation

Pediatric push

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be...
3:29 PM, Aug 10, 2018  |  BioCentury | Regulation

A new diagnosis

FDA has given up on the idea that diagnostic tests can be shoehorned into the medical device regulatory paradigm, and has asked Congress to create a new framework for oversight. Like FDA’s initiatives to revamp...
3:19 PM, Jul 27, 2018  |  BioCentury | Regulation

Getting into action

In its Biosimilars Action Plan, FDA promises to address most of the hot button regulatory issues that have slowed development of biosimilars and interchangeable biologics for the U.S. market. FDA can do little, however, to...
2:26 PM, Jul 27, 2018  |  BioCentury | Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
4:07 PM, Jul 20, 2018  |  BioCentury | Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
11:35 AM, Jul 12, 2018  |  BioCentury | Regulation

Making patients partners

FDA has rolled out the first of a series of planned guidance documents aimed at creating a road map for making patient experience data integral to every phase of medical product development. The guidance documents,...
5:59 PM, Jun 29, 2018  |  BioCentury | Regulation

Not a test

Antibiotics developers shouldn’t read too much into FDA’s rejection of the first drug to be reviewed under a new limited-use pathway that is supposed to make it easier to develop treatments for rare and resistant...
10:50 AM, Jun 29, 2018  |  BioCentury | Regulation

Biosimilars do-over

As part of an initiative to stimulate biosimilar competition, FDA is planning a do-over of draft guidance on statistical methods for demonstrating biosimilarity to a reference product. The agency announced on June 21 it was...
5:15 PM, Jun 22, 2018  |  BioCentury | Regulation

Emergency preparedness

Borrowing a page from the software industry, FDA Commissioner Scott Gottlieb believes that licensing rather than selling certain antibiotics could help address the crisis of multidrug resistant pathogens. He is hoping to work with CMS...