Considerations for the Design of Early-Phase Trials of Cellular and Gene Therapy Products; Guidance for Industry. Final. June 9, 2015. CBER
FDA Guidance. Assessment of Male-Mediated Developmental Risk for Pharmaceuticals
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals (Draft). June 11, 2015. CDER
FDA Guidance. Rare Diseases: Common Issues
Rare Diseases: Common Issues in Drug Development (Draft). August 2015. CEDR, CEBR
FDA Guidance. Brief Summary and Adequate Directions for Use
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Revised Draft). August 2015
New Alphabet hire Insel gears up for med tech mental health innovation
Alphabet’s ($GOOG) notable hire of late, Dr. Thomas Insel, is gearing up to start work next week at the Google Life Sciences group, and Insel is bringing big plans for med tech mental health innovation to the table. (FierceMedicalDevices)
CDRH unveils top regulatory science priorities for 2016
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. (RAPS Regulatory Focus)
Top 10 regulatory issues for today’s drug developers
Regulatory issues include — The FDA’s new Super Office of Pharmaceutical Quality; The new risk/benefit equation; 21st century pharmacovigilance; Biosimilars; Patient-focused drug development; and more. (YourEncore.com)
Why are cancer clinical trials increasing in duration?
www.appliedclinicaltrialsonline.com
We May be Overlooking a Critical Factor: Antiquated Endpoint Design…The reason why oncology trials in particular are increasing in duration is because standard of care (SOC) treatment options are soo good at prolonging life, however, regulators and payers still require that an oncology study’s primary endpoint focus on patient death. (AppliedClinicalTrials Online)