Comment from Kenvue Brands LLC part 3 of 4
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Summary: The provided text is a collection of various documents, including a legal filing regarding a lawsuit against Kenvue Brands LLC, an internal FDA memorandum regarding acetaminophen and ADHD, and several FDA news releases and health bulletins. It does not contain a specific public comment submitted in response to the "Citizen Petition from Americans for Scientific Integrity."
Submission 3 of 4 in support of Kenvue Brands LLC’s response to the Citizen Petition
Attachments
- Footnote 22_2 - In Re_ Acetaminophen - ASD-ADHD Products Liability Litigation (PDF)
- Footnote 24 - Memorandum to File by D. Charles Thompson Division of Nonprescription Drug Products (2016) (PDF)
- Footnote 28 - FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy_FDA News Release (PDF)
- Footnote 29 - Notice to Physicians on the Use of Acetaminophen During Pregnancy_FDA (PDF)
- Footnote 30b - No Circumcision Doesn't Cause Autism_O Rose Broderick (PDF)
- Footnote 31 - Health Bulletin_Use Caution with Pain Relievers (acetaminophen)_FDA (PDF)
- Footnote 32 - Safe Use Initiative - Current Projects_FDA (PDF)
- Footnote 33 - FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems_FDA (PDF)
- Footnote 34 - Questions and Answers on Compounded Oral Suspension Medications for Pain and Fever_FDA (PDF)
- Footnote 35 - Drug Shortages with CDR Emily Thakur_FDA (PDF)
- Footnote 36a - Acetaminophen_Acetaminophen Use in Infants and Children_FDA (PDF)
- Footnote 36b - Questions and Answers Important change in concentration (PDF)
- Footnote 38b - DEA_Controlled Substances - Alphabetical Order (PDF)
- Footnote 40b - Drospirenone (oral route)_Mayo Clinic
- Footnote 40c - Drospirenone and estradiol (oral route)_Mayo Clinic
- Footnote 41 - FDA Recommends Avoiding Use of NSAIDs in Pregnancy at 20 Weeks or Later Because They Can Result in Low Amniotic Fluid_FDA (PDF)
- Footnote 42 - Safety review update of codeine use in children (PDF)
- Footnote 43a - FDA Drug Safety Communication (PDF)
- Footnote 43b - FDA Drug Safety Communication_ FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older_FDA (PDF)
- Footnote 44 - Advisory Committee Calendar _ December 10 2015 (PDF)