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
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...
CDE Releases Guidelines for Chemically Synthesized Peptide Research
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Pharmaceutical Research of...
CDE Issues Guidelines for Real-World Drug Research and Evidence Framework
The Center for Drug Evaluation (CDE) has released two important documents: the “Guiding Principles of...
Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...