Submission of New Drug Applications and Abbreviated New Drug Applications

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

NDA, or New Drug Applications: Drug sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the U.S. through a New Drug Application using the data gathered during the animal studies and human clinical trials. Via a 505(b)(2) application, the NDA allows the usage of agency findings for a previously-approved drug and published literature and allows the FDA to determine whether the benefits of a drug outweigh the potential risks, whether the proposed packaging and insert is appropriate and whether manufacturing methods allow for adequate preservation of identity, strength, quality, and purity.

ANDA, or Abbreviated New Drug Applications (for Generic drugs) are “abbreviated” because they are generally not required to submit preclinical and clinical data to establish safety and effectiveness. Instead, generic applicants must demonstrate bioequivalence, or identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved reference drug.

EAS Consulting Group assists clients with filing drug applications. Our Senior Director of Drug and Device Services works with our team of drug application experts to determine the best course of action, designs the studies necessary to support this, and files the application and/or any subsequent supplements on the clients’ behalf.