U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that products that emit radiation
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Information to assist the drug manufacturing industry in the development of generic drugs and the completion of abbreviated new drug applications (ANDAs)
Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants
2024 NCTR Research Highlights and Accomplishments:
Compounding Pharmacy/Adulterated Drug Products
Drug Product/Adulterated
Drug Product/Adulterated
CDER - Biological Product Deviations
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has no
An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) are lower than previously suspected. These risks still exist, but we believe the benefits of quitting smoking outweigh them.
FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs.
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.
Frequently Asked Questions About Therapeutic Biological Products
This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and discussed with the Board. Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or Inst.
Discover FDA-approved products for anthrax preparedness and response. Get essential information on vaccines, treatments, and preventive measures to protect public health from bioterrorism threats like anthrax.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information
Stay informed on FDA updates and press announcements about recalls involving angiotensin II receptor blockers (ARBs) like valsartan and losartan. Discover key safety alerts, reasons for recalls, and the latest FDA actions to ensure drug safety and availability.
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
Interviews with experts from FDA's Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.
Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.
Drug Shortages Homepage
Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners.
When a child’s sniffles and sneezes won’t go away for weeks, the cause might be allergies. The FDA regulates prescription and OTC medicines that offer allergy relief, plus allergen extracts to diagnose and treat allergies. Read and follow the directions when giving any medicine to children.
Upcoming EL-PFDD Meetings
CDER Scientific Reviews Supporting EUA for Therapeutic Products
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.
Information regarding the FDA's efforts to support the development of clinical practice guidelines for drugs with abuse potential.
How to Report a Shortage or Supply Issue
This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee.
Working across the Agency, FDA’s Overdose Prevention priorities closely align with HHS and bring together our ongoing and proposed activities to strengthen FDA’s role in combatting the drug overdose crisis, including opioids.
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
“Q&A with FDA” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions
FDA Drug Safety Podcasts are produced by FDA's Center for Drug Evaluation and Research (CDER)
Voluntary recalls of acne products after FDA testing finds small number of proudcts with elevated levels of benzene
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Generic Drugs Offices and Divisions
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Data Descriptions updated (February 24, 2017)
CGMP/Finished Pharmaceuticals/Adulterated
CGMP/Finished Pharmaceuticals/Adulterated
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by
This page is a resource for ANDA Forms and Submission Requirements
News and Announcements updated
In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.
Unapproved New Drugs/Misbranded
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