Webinar: Regulatory Changes and Operational Challenges for Dx Developers

Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers [...]

Webinar: Regulatory Changes and Operational Challenges for Dx Developers 2018-08-14T21:01:45+00:00

Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical [...]

Differences Between Drug and Medical Device Trials: CSRs 2018-08-14T21:07:18+00:00

Addressing High Failure Rates in Drug Development

FDA has published an excellent report on 22 instances in which phase 2 and phase 3 trials had divergent results. Appendix A of the report provides justifications for essential elements of modern clinical trials, including a control group, randomization and blinding. In addition, Appendix A highlights risks of techniques for improving efficiency in early development, [...]

Addressing High Failure Rates in Drug Development 2018-08-14T21:09:03+00:00

Expedited Development for All: the Phase 2c Pathway

FDA's Expedited Programs for Serious Conditions, as well as the Orphan Drug Designation, remain exceptional by design. However, the time has come to consider ways of transforming the exception into the rule: providing the benefits of expedited programs beyond products for serious conditions with unmet medical needs. The success of FDA's expedited programs demonstrates that [...]

Expedited Development for All: the Phase 2c Pathway 2018-04-30T15:26:47+00:00

Debunking the Instant Myth of FDA as Rubber Stamp

FDA's high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here's the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of [...]

Debunking the Instant Myth of FDA as Rubber Stamp 2015-08-21T15:24:01+00:00

Independent Pre-FDA Draft Guidances from Stakeholders

The introduction to an FDA draft guidance for industry published in June 2015, "Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment," makes an unusual statement: Development of this guidance was preceded by the submission to FDA of a proposed draft guidance independently prepared by a consortium of stakeholders including patients, parents and caregivers, clinicians, [...]

Independent Pre-FDA Draft Guidances from Stakeholders 2015-08-04T14:58:03+00:00
SUBMIT RFP