Drugs@FDA/Reviews and Labels
“Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States.
- FDA-approved labeling for products for human use
- Therapeutically equivalent drug products, including generic drug products
- Product information for patients
- A product’s approval history, including approval letters (and FDA reviews)” – FAQs
“Includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Dates of Coverage: 1938-present. Update frequency: Daily.” – About
FDA Reviews of Drug Applications
Contemporary FDA drug review packages typically include FDA’s Benefit-Risk analysis, reviews of human data (Clinical/Medical/Clinical Pharmacology reports), data from in vitro studies and laboratory animals (Non-clinical/Pharmacology), Product Quality, Statistics, and Administrative and Correspondence documents, as well as a list of FDA staff involved in the review.
Full review packages are generally available for drugs approved since late 2002.
Benefit-Risk assessments can be found for most drugs approved since 2015.
Researchers, clinicians, industry professionals, and the public can use these documents to:
- Understand the scientific and regulatory basis for FDA approval decisions.
- Review data on safety, efficacy, and labeling as evaluated by FDA experts.
- Examine how disagreements within the review team or with the applicant were resolved.
- Gain insight into the FDA’s decision-making process, including the rationale for labeling, warnings, and post-marketing requirements.
- Identify key FDA staff involved in the review.
The presentation of the review package varies with approval year and product. Following are examples of representative formats.
How to Access Reviews
Scribe step-by-step “slides” – How to Find Clinical Reviews on Drugs@FDA
- Go to the Drugs@FDA Website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- Search for the Drug: In the search bar, type the brand name or active ingredient of the drug.
- Select the Correct Drug Product: Review the search results. Click on the drug name that matches your interest (correct dosage/formulation/brand if applicable).
- Open the Drug Approval History: On the drug’s page, scroll to the “Approval History, Letters, Reviews, and Related Documents” section. You will see a list of approval dates and corresponding documents.
- Locate the Clinical Review: Find a row with a document labeled “Clinical Review” (or sometimes “Medical Review”). It may be listed under the “Review” column. Click the PDF or link next to the relevant approval date to open the review.
- Review or Download: Open the PDF in your browser or download it.
Note: Sometimes clinical reviews may be bundled with other documents (e.g. in the Multidisciplinary Review package). Supplemental approvals may not include clinical reviews.
Articles on the Use of FDA Approval Packages
- How to use FDA drug approval documents for evidence syntheses (2018)
- The Need for Improved Access to FDA Reviews (2009)
- The Importance of FDA Approval Packages and Briefing Documents in Pharmacy Education (2009)
Center for Drug Evaluation and Research
FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. General information page and links to resources and databases.
Medication Guides
The Medication Guides database provides links to drug labels requiring a Medication Guide. The Guides are appendended to the standard drug label and can be found on the last page(s) of the combined document.
“Medication Guides (MGs) are a type of labeling for patients and caregivers that are required by the FDA when:
- The MG could help prevent serious side effects,
- The medicine has serious side effects (relative to benefits) in which patients should be made aware of, or
- Following directions for the use of the medicine is important for the medicine’s effectiveness.” – Medication Guides
Approved Drugs
Novel Drugs and New Molecular Entities
“Novel drugs are new drugs never before approved or marketed in the United States. Each year, CDER approves a wide range of new drugs and biological products. Some of these products have never been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. ” – Novel
Novel drug approvals by year: 2025…
Compilation of CDER New Molecular Entity (NME) and New Biologic Approvals 1985-2024 – Description – Download Excel
“This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2024 and regulated by the Center for Drug Evaluation and Research (CDER). The listed NMEs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under a Biologics License Application (BLA). The product information, indications, and regulatory characteristics described in the compilation reflect the state of each application at the time of original marketing approval.” – Compilation
Cell and Gene Therapies
Approved Cellular and Gene Therapy Products (through March 6, 2025) and description of what this class includes:
“Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” – CGT Products
FDA Advisory Committees
“When a scientific, technical, or policy question arises, such as whether an unapproved product is safe and effective, FDA often relies on advisory committees to provide independent advice. Committee members include scientific experts—such as physician-researchers and statisticians—and members of the public, including representatives of industry, consumers, and patients.” – Learn about
Upcoming Meetings
- July 17, 2025 – Belantamab mafodotin (BLA 761440) – Submitted by GlaxoSmithKline LLC, for the treatment of adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide.
- July 18, 2025 – Rexulti (brexpiprazole) tablets (supplemental New Drug Application [sNDA] 205422/S-012) – Submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of treatment of adults with post-traumatic stress disorder (PTSD), in combination with sertraline.
Recent Meetings
- Long-term Opioid Use – YouTube – Findings of the completed extended-release/long-acting opioid analgesic (ER/LA OA) postmarketing requirements (PMRs) 3033-1 and 3033-2. These PMRs are prospective (3033-1) and retrospective (3033-2) epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain, including patients prescribed ER/LA OAs.
- Condoliase injection (BLA 761393) – Submitted by Seikagaku Corp., for the proposed indication of the treatment of radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults (2025).
- Pediatric RSV Vaccine – Respiratory Syncytial Virus [RSV] Vaccine Safety in Pediatric Populations (2024).
- Andexxa (sBLA) 125586/546 – Supplemental biologics license application for Andexxa (coagulation factor Xa (recombinant), inactivated -zhzo), for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- Clozapine – Risk Evaluation and Mitigation Strategy (REMS) for Clozapine Products.
- Sotagliflozin oral tablet (210934) – Submitted by Lexicon Pharmaceuticals, Inc., for the proposed indication, as an adjunct to insulin therapy, to improve glycemic control in adults with type 1 diabetes mellitus and chronic kidney disease.
FDA Guidances | Drugs
Recommendations from US FDA to drug manufacturers regarding the development of drugs. All guidance start with the following statement, “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.” The applicable statues and regulations, can be found in the the US Code of Federal Regulations (CFR) Title 21 – Food and Drugs.
Representative Guidance for Industry
- Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction – Draft (2025)
- Benefit-Risk Assessment for New Drug and Biological Products – Final (2023).
- Must listen to Podcast discussing guidance.
- Psychedelic Drugs: Considerations for Clinical Investigations – Draft (2023)
- Migraine: Developing Drugs for Preventive Treatment – Draft (2023)
- Homeopathic Drug Products Guidance for FDA Staff and Industry – Final (2022)
- Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final (2009)
- Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format – Final (2006)
Drug-Induced Organ Toxicity
FDA YouTubes
Make sure to also check out the new series “FDA Direct” with FDA Commissioner Marty Machary – the first episode was posted May 8, 2025.