News & Analysis as of

Biotechnology › Patient Access › Clinical Trials

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Hogan Lovells

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Hogan Lovells

New rules for expanded access in Italy

Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide