CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report,...
CDE
CDE Releases 73rd Batch of Chemical Generic Reference Preparations with Updates
The Center for Drug Evaluation (CDE) has released the 73rd batch of chemical generic reference...
CDE Seeks Public Feedback on Biological Product Changes During Clinical Trials
The Center for Drug Evaluation (CDE) is once again seeking public feedback on two key...
CDE Releases Draft Guidelines for Clinical Pharmacology Research of Chemical Modified Drugs
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Pharmacological Research...
CDE Issues Guiding Principles for Natural History Research in Rare Disease Drug Development
The Center for Drug Evaluation (CDE) has released the “Guiding Principles for Natural History Research...
CDE Launches Technical Guidelines to Emphasize Patient-Centered Drug Clinical Trials
The Center for Drug Evaluation (CDE) has released a series of Technical Guidelines that encompass...
Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug...
CDE Launches Trial Procedures for Adding Pediatric Information to Drug Inserts
The Center for Drug Evaluation (CDE) has released the “Work Procedures for Adding Children’s Drug...
CDE Releases 72nd Batch of Generic Reference Preparations with New Specifications
The Center for Drug Evaluation (CDE) has released the 72nd batch of chemical generic reference...
CDE Issues Guidelines for New Drug Benefit-Risk Assessment in Market Approval Filings
The Center for Drug Evaluation (CDE) has released a notice outlining the guidelines for “New...
CDE Releases Guidelines for Clinical Trials of Stem Cell Therapies and Derived Products
The Center for Drug Evaluation (CDE) has released a set of “Guidelines for Clinical Trial...
CDE Releases Draft Guidelines for Antibody Drug Conjugate Research and Evaluation
The Center for Drug Evaluation (CDE) has released a draft set of “Guiding Principles for...
CDE Releases 71st Batch of Generic Reference Preparations with Updates and New Injecables
The Center for Drug Evaluation (CDE) has released the 71st batch of chemical generic reference...
CDE Releases 70th Batch of Generic Reference Preparations for Public Feedback
The Center for Drug Evaluation (CDE) has released the 70th batch of chemical generic reference...
China’s CDE Unveils Technical Guidelines for Stem Cell Products and Immunotherapy in Chronic Hepatitis B
The Center for Drug Evaluation (CDE) has released a series of Technical Guidelines aimed at...
CDE Launches Guidelines to Expedite Pediatric and Rare Disease Drug Reviews
The Center for Drug Evaluation (CDE) has unveiled a new set of “Work Specifications to...
CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Development
The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on...
CDE Issues New Guidance on Pre-Phase III Clinical Trial Meetings for Innovative Drugs
The Center for Drug Evaluation (CDE) has released the “Innovative Chemical Drug Pre-Phase III Clinical...
CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Clinical R&D
The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on...
CDE Releases Guidance on Pre-Phase III Clinical Trial Meetings for Innovative Chemical Drugs
The Center for Drug Evaluation (CDE) has released the “Innovative Chemical Drug Pre-Phase III Clinical...