The FDA Law Blog
MAY 23, 2023
Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.
The FDA Law Blog
JUNE 11, 2023
This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA.
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The Checkup by Singlecare
AUGUST 14, 2024
Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use. First, using a drug off-label—especially one that’s fairly new, like Ozempic—can be unsafe.
European Pharmaceutical Review
NOVEMBER 24, 2022
These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.
The Checkup by Singlecare
JANUARY 4, 2024
In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. Read all medication labels and consult a healthcare provider for medical advice before consuming alcohol while taking medications for cough and cold symptoms. appeared first on The Checkup.
The Checkup by Singlecare
FEBRUARY 9, 2023
Wellbutrin is approved by the Food and Drug Administration (FDA) for the management of major depressive disorder (MDD), the prevention of seasonal affective disorder (SAD), and smoking cessation, but is used off-label for several conditions including weight loss, SSRI-induced sexual dysfunction, and attention-deficit hyperactivity disorder ( ADHD ).
The FDA Law Blog
FEBRUARY 28, 2023
Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. New Labeling Requirements. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).
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