Human Drugs
AlgoTherapeutix ATX01 Orphan Drug Status
FDA grants AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia.
Medical Devices
Revised EUA Bans China Decontaminated Respirators
FDA reissues certain emergency use authorizations to identify specific respirators that can be decontaminated for reuse.
Human Drugs
42% of FDA Drug Quality Inspections Done in U.S.
A new FDA drug quality annual report finds that the agency in 2019 performed 1,258 drug quality surveillance inspections, with 42% of these conducted ...
Human Drugs
Farley Appointed FDA Antimicrobial Products Director
CDER Office of Antimicrobial Products deputy director John Farley is named permanent director.
Human Drugs
FDA Relaxes Drug Sample Enforcement
FDA posts a guidance on a temporary Policy to make it easier for drug firms to distribute drug samples During the Covid-19 public health emergency.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Medical Devices
Abiomed Small Heart Pump Study Approved
FDA approves an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Cardiac Power heart pum...
Federal Register
PDUFA Reauthorization Virtual Meeting
Federal Register notice: FDA announces a 7/23 virtual public meeting on Reauthorization of the Prescription Drug User Fee Act.
Human Drugs
Electronic Signatures Addressed in Clinical Trial Q&A
FDA adds a new section to a clinical trial guidance that discusses 21 CFR Part 11 compliance for electronic systems used to generate electronic signat...
Medical Devices
FDA Guide on Patient Remote Monitors
FDA posts a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coro...
