PHUSE obtains two TransCelerate guidance tools to help promote clinical data transparency and patient privacy – PHUSE
PHUSE announced its successful transition of two guidance papers from TransCelerate BioPharma Inc. The guidance documents address clinical data transparency and data anonymization.
Read the full press release here
Statement on agency’s efforts to increase transparency in medical device reporting – U.S. Food & Drug Administration
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health is updating its Medical Device Reporting (MDR) Program. The FDA uses this program to monitor device performance, safety concerns, and other factors.
View the full statement on the FDA newsroom
Postmarketing commitments for novel drugs and biologics approved by the U.S. Food and Drug Administration: a cross-sectional analysis – BMC Medicine
Researchers studied how often postmarketing commitments agreed upon by pharmaceutical companies at first FDA approval lead to new clinical trials. The researchers found that while only 15% of postmarketing commitments agreed to by pharmaceutical companies at the time of FDA approval were for new clinical trials, these trials were nearly always registered with reported results on ClinicalTrials.gov. However, only half were published, and despite FDA public reporting requirements.
Access the full study here