FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Latex Gloves Need 510(k); More Surveillance

[ Price : $8.95]

Federal Register notice: FDA clarifies that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon a...

Opdivo OKd for Gastric Cancer

[ Price : $8.95]

FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients ...

BD Recall of Alaris Pump Due to Keypad

[ Price : $8.95]

Becton Dickinson recalls (Class 1) its CareFusion 303 Alaris Pump Module because of the risk of the keypad lifting up due to fluid...

Lilly Asks FDA to Revoke EUA for Bamlanivimab Alone

[ Price : $8.95]

Eli Lilly asks FDA to revoke its Emergency Use Authorization for bamlanivimab (LY-CoV555) 700 mg alone due to the growing prevalen...

Breakthrough Status for Breast Cancer Imager

[ Price : $8.95]

FDA grants Perimeter Medical Imaging AI a breakthrough device designation for its Optical Coherence Tomography Imaging System coup...

Workshop on Morphine Milligram Equivalents

[ Price : $8.95]

Federal Register notice: FDA announces a 6/7-8 public workshop entitled Morphine Milligram Equivalents: Current Applications and K...

Covid Led to Multiple Work Delays: CDRH

[ Price : $8.95]

CDRH says its response to the significant Covid-19 workload has led to delays in other product reviews.

Cut GDUFA Fees to Promote Competition: Analysis

[ Price : $8.95]

Harvard University professors say FDA could use a change in the GDUFA fee structure to increase generic drug competition.

FDA Taps Intertek for Device Conformity Assessments

[ Price : $8.95]

FDA selects Intertek as an accredited testing laboratory under the agencys Accreditation Scheme for Conformity Assessment Pilot Pr...

Critical Path Innovation Meeting MAPP

[ Price : $8.95]

CDER issues a MAPP outlining responsibilities for the critical path innovation meeting program.