Tin tức y dược
Breaking news, cập nhật luật, thông báo FDA / EMA / WHO / Bộ Y tế các nước.
- FDA
Newly Added Guidance Documents
Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
- FDA
M11 Clinical Electronic Structured Harmonised Protocol
M11 Clinical Electronic Structured Harmonised Protocol
- FDA
Generic Drug User Fee Amendments
This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
- FDA
BsUFA IV: Fiscal Years 2028-2032
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
- FDA
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis.
- FDA
Untitled Letters
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
- FDA
Generic Drug Facilities, Sites and Organization Lists
Generic Drug Facilities, Sites and Organization Lists
- FDA
First Generic Drug Approvals
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati
- FDA
2025 First Generic Drug Approvals
2025 First Generic Drug Approvals
- FDA
HIV Treatment
Get information about drugs approved to treat HIV
- FDA
CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation
- FDA
Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.
- FDA
Prescription to Nonprescription Switch List
Prescription to Nonprescription Switch List
- FDA
What's New Related to Drugs
Want 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.
- FDA
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
- FDA
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
- FDA
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
- FDA
President's Emergency Plan for AIDS Relief (PEPFAR)
Presidential Emergency Plan for AIDS Relief content
- FDA
GDUFA Paid Facilities List
This 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:
- FDA
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
- FDA
Human Drug Compounding Outsourcing Facility Fees
Human Drug Compounding Outsourcing Facility Fees
- FDA
Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System
Certain labels used with i.v.STATION automated compounding systems may not be detected, leading to mislabeled sterile filled syringes.
- FDA
Early Alert: Heart Pump Controller Issue from Abiomed
A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
- FDA
Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
React Health is removing affected devices due to a manufacturing process deviation that may result in an undetected oxygen leak condition.
- FDA
FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products