Issue Information
No abstract is available for this article.
FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD
The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder…
Ultra Seal Corporation – 624650 – 09/25/2024
CGMP/Finished Pharmaceuticals/Adulterated
Azurity Pharmaceuticals, Inc. – 656489 – 09/20/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Nomida.biz – 687590 – 09/12/2024
Unapproved New Drugs/Misbranded
Aerosol and Liquid Packaging, Inc. – 676746 – 07/24/2024
CGMP/Finished Pharmaceuticals/Adulterated
Accupack Midwest, Inc. – 680228 – 08/15/2024
CGMP/Finished Pharmaceuticals/Adulterated
Media Networks Sydney Pty Limited – 687044 – 09/18/2024
Failure to Register and List
Conducting Remote Regulatory Assessments Questions and Answers
Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry