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CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
… -documents-supporting-emergency-use-authorizations-drug-and-biological … To promote public confidence in FDA’s scientific … supporting Emergency Use Authorizations (EUA) for drug and biological therapeutic products as appropriate and consistent … scientific reviews after new drug and biological product approvals. Certain information may be redacted that is exempt …
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry
… imits-during-development-investigational-oncology-drugs-and-biological-products … New approvals in oncology often build on prior success by adding … During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry … FDA-2020-D-1294 … …
Approved Blood Products
… The following products are regulated as Premarket Approvals (PMAs) : Devices associated with blood donor … Tests Blood Grouping and Phenotyping Reagents Licensed Biological Products with Supporting Documents New Drug … Approved NDA and ANDA Application Submissions Premarket Approvals (PMAs) Premarket Approvals and Humanitarian Device …
2018: A Year of Innovation, Efficiency, and New Advances in Drug Therapy for the American Public
… known as "novel" drugs, along with a wide variety of approvals of drugs already on the market to put to new and innovative uses. Many of these new approvals will have a significant impact on improving—and … access, and potentially reduce the cost of important biological drug therapies. Of course, even the best drug …
FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
… build on its obligation to share information about product approvals. We’re especially focused on information that can … effective use. This information is included in our drug approvals database , Drugs@FDA. These summaries provide … security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The …
FDA In Brief: FDA seeks public feedback on new drug approval transparency efforts
… ways to build on how we share information about product approvals. We are especially focused on information that can … in the regulatory decision-making process for drug and biological products assessed by the FDA’s Center for Drug … security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The …
Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
… and result in additional safe, effective, and affordable biological product (biologic) treatments. Recognizing the … to speed up product development. To date, most biosimilar approvals have included pharmacokinetic (PK) similarity data … PD similarity studies rely on PD biomarkers, which are biological molecules that signal a normal or abnormal …
Cell and Tissue Products for Animals
… Products (ACTPs) Information about Marketed Products Approvals Currently, no ACTPs are FDA-approved. Risk … for Industry (GFIs 218, 253, and 254), regulatory actions (approvals) and policy (enforcement discretion), and CVM …
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation
… the 40-year record we set in 2017 of 99[ 1 ] novel device approvals, and capping off eight years of steady improvement. … security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The … device innovations, with record-setting 106 novel device approvals, and new actions FDA is taking to modernize …
Webinar Transcript: Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products
… and enrichment design allowed you to do that, you can see approvals in oncology with at most a couple of hundred … For Clinical Trials To Support Approval Of Human Drugs And Biological Products – March 25, 2013 ResourcesForYou FDA … For Clinical Trials To Support Approval Of Human Drugs And Biological Products â March 25, 2013 … Center for Drug …
Novel Drug Approvals for 2024
… /drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 … Helping Guide the … When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and … Each year, CDER approves a wide range of new drugs and biological products: Some of these products have never been …
FDALabel: Full-Text Search of Drug Product Labeling
… customizable searches of over 147,000 human prescription, biological, over-the-counter (OTC), and animal drug labeling … 2024 Human OTC Drugs* 92,176 Human Prescription Drugs and Biological Products** 57,293 Animal Prescription and Animal … Summit on Regulatory Science ( GSRS ) Other Resources Drug Approvals and Databases Drug Information for Consumers …
Novel Drug Approvals for 2015
… /drugs/novel-drug-approvals-fda/novel-drug-approvals-2015 … 2015 Novel Drugs … innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and … new therapies to market. The availability of new drugs and biological products often means new treatment options for …
FDA In Brief: FDA highlights record-breaking number of generic drug approvals in October
… da-brief-fda-highlights-record-breaking-number-generic-drug-approvals-october … November 9, 2018 Media Inquiries … security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The … FDA highlights record-breaking number of generic drug approvals in October …
FDA’s Labeling Resources for Human Prescription Drugs
… changes from efficacy supplements and labeling supplement approvals. These labeling changes include changes: … of Prescribing Information for Human Prescription Drug and Biological Products - Content and Format (July 2018) (when … to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances. Biosimilar …
FDA Approved Many New Drugs in 2022 That Will Improve the Lives of Patients and Consumers
… as “novel” drugs, as noted in our annual New Drug Therapy Approvals report . We also approved drugs in new settings, … also approved two interchangeable biosimilars, which are biological products that may (subject to state law) be … about CBER actions, visit CBER’s web page for 2022 Biological Approvals. The decision to approve a therapy …
Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues
… brought on by the ongoing COVID-19 pandemic. These new approvals, spanning a wide range of diseases and conditions, … two interchangeable biosimilar products in 2021, which are biological products that may be substituted without the … about CBER actions, visit CBER’s web page for 2021 Biological Approvals. I enjoy working with so many talented …
Information for Health Care Professionals | Drugs
… … Popular Topics Drug Approvals and Databases Drugs@FDA FDA Updates and Press … Drugs@FDA Includes information about drugs, including biological products, approved in U.S. Database; Drug … Drug Information Purple Book FDA-licensed (approved) biological products regulated by CDER Database Division of …
FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics - 02/03/2022
… to speed the application review process for new drugs and biological products without compromising FDA’s high standards … States’ drug approval process. It reversed the lag in drug approvals that prompted its creation, providing Americans … below, this is a consistent pattern for novel drugs and biological products and while it may also be influenced by …
Quick Guide to Web Resources
… … CBER Product Approvals/Clearances and Establishments CBER's Licensed … Actions (CBER) Warning Letters Untitled Letters (CBER ) Biological Product Deviations Biological Product Deviation Reports Annual Summaries …
FDA's Efforts to Advance the Development of Biologics
… The Center’s diverse regulatory portfolio of complex biological products includes blood components and … blood and tissue products. The safety and efficacy of the biological products regulated by the FDA are inextricably … attack on the cancer. Critical Vaccine and Blood Product Approvals In FY 2018, there were also critical vaccine and …
Accelerating Rare disease Cures (ARC) Program
… Diseases: Considerations for the Development of Drugs and Biological Products FDA Creates New Advisory Committee for … and Conduct of Externally Controlled Trials for Drug and Biological Products FDA Launches AATD Pre-Consortium … CDER Continues to Make Rare Diseases a Priority with Drug Approvals and Programming to Speed Therapeutic Development …
CBER Rare Disease Program
… history of regulating and advancing development of biological products for use in rare diseases and conditions. … advice to medical researchers and manufacturers of complex biological products throughout the development process. In … drugs and biologics that treat rare diseases. CBER Orphan Approvals CBER's new Biologics License Application Approvals …
Search for Regulatory References | Drugs
… Biosimilar Product Information (FDA-Approved List of Biological Products) Biologics, Biosimilars, Biologics … (BLA) Frequently Asked Questions About Therapeutic Biological Products Biologics, Biosimilars, Biologics License … Acronyms and Abbreviations Search Databases Drug Approvals and Databases Databases Drugs@FDA Databases …
Access to Affordable Medicine - 06/19/2019
… and approval — and facilitate access to lower-cost biological products to treat a growing number of chronic and … FY 2018, the first full year of GDUFA II, FDA granted 971 approvals, of those 781 were full approvals and 190 were … programs currently enrolled in FDA’s Biosimilar Biological Product Development Program for 36 different …