Subscribe to
this category
r

Regulatory

A total of 64 posts are filed under Regulatory
Why Rare Disease Drug Developers Need Regular Interaction with the FDA
Despite accelerated pathways for the development and approval of rare disease therapies, significant challenges remain for companies wishing… Continue Reading
FDA Issues Draft Guidance on Pre-IND Meetings for Rare Disease Drug Development
Rare Daily Staff The U.S. Food and Drug Administration issued a draft guidance addressing the role of meetings with the agency prior to… Continue Reading
Making the Case for an FDA Rare Disease Center of Excellence
Two attorneys specializing in regulatory law recently proposed the creation of an FDA Rare Disease Center of Excellence to better allow the… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in September 2018
Continue Reading
FDA Awards 12 Grants to Fund Clinical Trials to Advance Rare Disease Treatments
Rare Daily Staff The U.S. Food and Drug Administration said that it has awarded 12 new clinical trial research grants totaling more than $18… Continue Reading
Proposal Calls for Creation of FDA Rare Disease Center of Excellence
Rare Daily Staff A pair of attorneys specializing in regulatory law have authored a proposal that calls for the creation of an FDA Rare… Continue Reading
Greater Transparency Would Improve Patients’ Understanding of FDA Actions
When the U.S. Food and Drug Administration declines to approve a new medicine, its delivers the news to the drug developer in what’s known… Continue Reading
be-a-guest-blogger

Follow us on Twitter