U.S.FDA DETENTION – DRUG
Most of the drugs detained by U.S.FDA are due to non-compliance with U.S.FDA requirements.
The most common reasons U.S.FDA detain Drugs:
- Drug establishment is not registered with U.S.FDA
- Drug product is not listed with U.S.FDA
- Active Pharmaceutical Ingredients (API) is not listed with U.S.FDA
- OTC Drug Product doesn’t follow OTC Monograph
- Drugs / API’s doesn’t have proper labeling
Docent Pharma’s Regulatory Consultant/Specialist assists exporters and importers to release the detained drugs by brought the drugs in to compliance with the U.S.FDA regulations.
U.S. FDA PLAIR SUBMISSION
A Pre-Launch Activities Importation Request, also known as a PLAIR, is permit importation of unapproved finished dosage form drug products based upon anticipated approval of a new drug application (NDA), an abbreviated new drug application (ANDA), or a Biologics License Application (BLA) regulated by U.S.FDA’s Center for Drug Evaluation and Research (CDER) to prepare the drug products for market launch.
Docent Pharma’s Regulatory Consultant/Specialist assists you to applying and obtaining the PLAIR for your drug product prior to U.S.FDA approval.