Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
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FDA Drug Safety Podcasts are produced by FDA’s Center for Drug Evaluation and Research (CDER)
Firehook of Virginia Issues Allergy Alert on Undeclared Sesame in Classic Sea Salt Crackers
Firehook of Virginia is recalling one lot of Firehook brand Classic Sea Salt Organic Crackers because they may contain undeclared sesame.
East Orange VA Medical Center. East Orange, NJ. 483 issued 04/29/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/29/2025
Short Title (70 char) East Orange VA Medical Center. East Orange, NJ. 483 issued 04/29/2025
FEI Number 3011110195
Firm Name East Orange VA Medical Center
Record Type 483
State NJ
Establishment Type Pr
Record Date 04/29/2025
Short Title (70 char) East Orange VA Medical Center. East Orange, NJ. 483 issued 04/29/2025
FEI Number 3011110195
Firm Name East Orange VA Medical Center
Record Type 483
State NJ
Establishment Type Pr
OII Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 03/23/2020
Short Title (70 char) Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
FEI Number 3016619230
Firm Name Vibrant K9
Record Type Sample Analysis
State CA
Establishment Type Pet Food Manufactu
Record Date 03/23/2020
Short Title (70 char) Vibrant K9. Oak Hills, CA. Sample Analysis issued 03/23/2020
FEI Number 3016619230
Firm Name Vibrant K9
Record Type Sample Analysis
State CA
Establishment Type Pet Food Manufactu
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.