Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after […]

By: Theresa Mullin, Ph.D., CDER’s Associate Center Director for Strategic Initiatives, and Michael Kopcha, Ph.D., R.Ph., director of CDER’s Office of Pharmaceutical Quality FDA and the […]

Docket Number: FDA-2017-D-6209 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides information to stakeholders […]

Reference #: FEI 3009167769 Product: Drugs Recipient: Recipient Name Mr. K. K. Singh Recipient Title Chairman Kumar Organic Products Limited Plot No. 379 Canal RoadMaitri Marg, […]

Delivery Method: VIA UPS Reference #: 320-20-34 Product: Drugs Recipient: Recipient Name Mr. K. K. Singh Recipient Title Chairman Kumar Organic Products Limited Plot No. 379 […]

Prescription stimulants are classified as Schedule II drugs under the Controlled Substances Act and associated with serious risks, including misuse, addiction, overdose, and diversion. Stimulants are […]

What’s New What is the CDER Quality Standards Program? The CDER Quality Standards Program will help promote innovation in pharmaceutical development and manufacturing and streamline the […]

CDER researchers conducted a study of the antiepileptic drug, lamotrigine, comparing generic lamotrigine extended-release (ER) tablets and brand ER tablets in healthy subjects. Their finding that […]

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]