U.S.FDA DETENTION
For Drugs Non-compliance with U.S.FDA Requirement Manufacturer/Exporter/Importer

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.