The Office of Generic Drugs (OGD) in the US Food and Drug Adminstration's (FDA) Center
for Drug Evaluation and Research (CDER) has recently been receiving unprecedented …

The ever increasing workload at the Office of Generic Drugs (OGD) within the US Food and
Drug Administration's Center for Drug Evaluation and Research (CDER) has led the office to …

BACKGROUND: The US Food and Drug Administration (FDA) is the regulatory agency
responsible for approving all pharmaceutical products marketed in the United States. While …

The United States Food and Drug Administration (USFDA) is one of the main regulated
agencies wherein the submission and approval of the new drugs is done. This review is …

Excipient Insider sidered new. Changes to specifications or manufacturing methods for an
approved excipient must be included in NDAs or NDA supplements but do not indicate a …

Oxford Pharmaceutical Resources, Inc., Totowa, New Jersey, USAI
INTRODUCTIONSubmitting a New Drug Application (NDA) to the FDA requires a …

ABSTRACT A drug master file (DMF) is a confidential, detailed document submitted by
Active Pharmaceutical Ingredient (API) manufacturers to the US Food and Drug …

Several tables are presented which provide data related to drug approvals, subsmission,
and labeling which include the new drugs being approved by the US Food and Drug …

The FDA defines a generic drug as a “medication created to be the same as an already
marketed brand-name drug in dosage form, safety, strength, route of administration, quality …

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to
FDA Approval Requirements provides indispensable and practical insights into the FDA …