- by FDADrug Shortages homepage
- by FDAHuman drug compounding; FDA inspections; compounding recalls
- by FDACompounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individua
- by FDAAntimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.
- by FDAWant to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
- by FDAInnovative drugs often mean new treatment options for patients and advances in health care for the American public.
- by FDAThis page contains the DODAC roster, which lists the current members and the current number of vacancies for the committee.
- by FDADrug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approv
- by FDAMedication Health Fraud products that are tainted Sleep Aid Products
- by FDAIn anticipation of potential OTC monograph drug dosage form innovation, FDA is seeking ways to further define features of nonprescription drug products that could be considered “candy-like.”
- by FDAGeneric Drug Facilities, Sites and Organization Lists
- by FDAThis page is a resource for ANDA Forms and Submission Requirements
- by FDAThis list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:
- by FDASeptember 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.
- by FDAIncreasing the Efficiency of Biosimilar Development Programs–Reevaluating the Need for Comparative Clinical Efficacy Studies
- by FDAThe U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
- by FDAFiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.
- by FDAThe purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by CDER and CBER
- by FDASponsored or co-sponsored by Center for Drug Evaluation and Research
- by FDAMitigating Risks from Human Xylazine Exposure