Human Drugs
Suggestions to Change Cancer Placebo Guidance
Five major drug companies suggest changes to an FDA draft guidance on using placebo controls in cancer clinical trials.
Human Drugs
7 Observations in MedisourceRx FDA-483
FDA releases the FDA-483 with seven observations following an inspection at MedisourceRx.
Federal Register
Guide on Developing Fixed-Combination Hypertension Drugs
Federal Register notice: FDA makes available a final guidance entitled Hypertension: Developing Fixed- Combination Drug Products for Treatment.
Medical Devices
MRI Interventions ClearPoint Software Upgrade
FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.
Human Drugs
FDA Transitional Biologics Position Ripe for Litigation: Attorneys
Attorney Scott Lassman says protein drug sponsors may sue FDA over a 2016 draft guidance on requiring BLAs for such products as of 3/20/20.
Human Drugs
FDA Releases Akorn FDA-483 with 11 Observations
FDA releases the latest FDA-483 detailing problems at another Akorn manufacturing facility, this time in Somerset, NJ.
Human Drugs
Generic Drug Industrys Trade Agreement Concerns
The Association for Accessible Medicines calls for changes to the proposed U.S.-Mexico-Canada Free Trade Agreement to better protect generic drugs and...
Human Drugs
Facilitating Surrogate Endpoints in Drug Development
FDAer Abena Agyemanm says the agency has published a table of surrogate endpoints that were used or could be used to indicate efficacy in drug develop...
Human Drugs
Ortho Vitros HIV Test Approved
FDA approves Ortho Clinical Diagnostics Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Orthos Vitros 5600 Integrate...
