HP&M Attorney Pens the Case for Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials (Mar 19, 2019 19:54)
By James E. Valentine —

A Doggone Shame for Vanda: DC District Court Grants FDA’s Remand Motion on Dog Study/IND Clinical Hold Challenge (Mar 18, 2019 21:10)
By Sara W. Koblitz —

To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device Establishments (Mar 17, 2019 19:12)
By Rachael E. Hunt —

Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet Form (Mar 14, 2019 22:06)
By Larry K. Houck —

Enforcement Updates: OPDP Issues First Letter of the Year (Mar 13, 2019 07:36)
In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been dimi...

Emerging Technology: Implanted Brain Computer Interface Devices for Patients with Paralysis or Amputation (Mar 13, 2019 01:26)
By Adrienne R. Lenz, Senior Medical Device Regulation Expert —

Let’s Play Name That Biosimilar! (Mar 12, 2019 05:58)
By Sara W. Koblitz —

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