internal audit / approval applications / generic drug manufacturer / lesser-known tools / manufacturing controls documentation / drug approval applications / application or applications / abbreviated and new drug applications / manufacturing specifications / fraudulent applications / finished drug products / active pharmaceutical ingredients / manufacturing processes / premarket approval applications / /
Organization
Division of Manufacturing and Product Quality / CDER’s office of Compliance / office of Compliance / office of Regulatory Affairs / FDA / Center for Drug Evaluation and Research / Dewas / Paonta Sahib and Batamandi Unit / /
Person
Janet Woodcock / Jim Edwards / Compliance / Paula Katz / Deborah Autor / George Eliot / Malvinder Mohan Singh / / /
Position
investigator / Director / CEO and Managing Director / consultant / major producer / Regulatory Counsel / /
FOOD AND DRUG LAW JOURNAL Enforcement Analyzing the Laws, Regulations, and Policies