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People also ask
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What is FDA Form 3911 used for?
The Drug Supply Chain Security Act (DSCSA) mandates the use of FDA form 3911, crucial for ensuring the traceability and accountability of prescription drugs. Form 3911, known as "Comprehensive Recall Request," is a tool used by pharmaceutical stakeholders to notify the FDA about drug recalls and product safety issues.
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Does FDA accept Cioms forms?
Pre- and postmarketing safety reporting of foreign events may continue to be reported to FDA on the CIOMS I form (Ref. 2). After consideration of the comments, the final rule, unlike the proposed rule, permits use of the CIOMS I form for this purpose without prior FDA approval.
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What is an FDA prior notice form?
Advance notice of import shipments allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation's food supply against terrorist acts and other public health emergencies.
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Does Librela have bad side effects?
While not all dogs will experience side effects, some common side effects of Librela include mild injection site reactions, such as swelling and heat. More serious side effects have also been reported, including renal and urinary tract disorders, neurological disorders, and gastrointestinal issues.
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How do I report an adverse reaction to Zoetis?
For questions about Zoetis products or to report a product defect, contact the Customer Service team in your region using the contact tool below. In the U.S., call 1-888-Zoetis1 (1-888-963-8471).
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How to report adverse drug reaction veterinary?
How to report? to your vet or retailer: Its a good idea to let your vet know if your animal has experienced a reaction. to the Marketing Authorisation Holder (MAH): Contact details are always given on the product packaging and leaflet.
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Can Librela cause neurological problems?
Does Librela cause neurologic symptoms? There have been reports of dogs developing new or worsening ataxia (uncoordinated gait) and/or paresis (weakness) after starting Librela. Librela was not studied in dogs with neurological disease that would interfere with assessment of the dog's mobility.
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How do I report side effects to Librela?
CONTACT INFORMATION To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Zoetis Inc. at 1-888-963-8471.
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