Human Drugs
Senators Introduce FDA Provisional Approval Bill
Senators Mike Braun (R-IN), Lisa Murkowski (R-AK), and Martha McSally (R-AZ) introduce the Promising Pathway Act (S. 3872) that would establish a roll...
Federal Register
IRB Individual Patient Expanded Access Reviews Guide
Federal Register notice: FDA makes available a final guidance on IRB reviews of individual patient expanded access requests.
Medical Devices
Antibody Test Validation Data Posted
FDA posts test performance data from four antibody test kits from an independent performance validation study effort with the National Institutes of H...
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...
