FDA Related News

Number of FDA Port of Entry Agents Up

FDA outlines for the House Energy and Commerce Committee its staffing levels of Port of Entry special agents tasked with stopping the flow of illicit ...

Medical Devices

FDA Pulls 2 Medical Device Proposed Rules

FDA says it will pull two proposed regulations that need further work if they are to be finalized.

Human Drugs

Court Backs FDA in MiraLax OTC Decision

The DC Circuit Appeals Court says FDA did not act arbitrarily or capriciously in determining that there is no meaningful difference between Rx and OTC...

Federal Register

Information Collection Extension for Bar Code Labels

Federal Register notice: FDA seeks comments on an information collection extension entitled Bar Code Label Requirement for Human Drug and Biological P...

Medical Devices

FDA Clears EliTechGroup Herpes Test

FDA clears an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument.

Medical Devices

Stimwave Mobile Platform Cleared for Pain Device

FDA clears a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management.

Human Drugs

FDA Speeding Drug Approvals: Pitts

Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.

Federal Register

FDA Science Advisory Board Meeting 12/4-5

Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Research.

Medical Devices

Implantable Orthopedic Device Reprocessing Petition

A University of Toledo professor says FDA should stop clearing or approving reprocessing of pedicle screws and other implantable orthopedic devices.

Human Drugs

SciGen Recalls Irbesartan for Contamination Potential

FDA says SciGen is recalling specific lots of its irbesartan due to a potential for contamination.