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Human Drugs

Comments Sought on Radioactive Drug Committee Reporting

Federal Register notice: FDA seeks comments on an information collection extension on Radioactive Drug Research Committees OMB Control Number 09100053...

Human Drugs

BMS, Transgene Collaborate on Lung Cancer Combination

Bristol-Myers Squibb and Transgene enter into a clinical research collaboration to evaluate Transgenes investigational therapeutic vaccine TG4010 in c...

Human Drugs

Challenges in Using a Single IRB in Multisite Trials

Three professors raise issues to be resolved before a requirement for a single IRB in multi-site studies can be implemented.

FDA General

Executive Order on Reducing Regulations Analyzed

Two Venable attorneys describe opportunities for stakeholders that could be part of President Trumps executive order on reducing regulations and their...

Human Drugs

Sentinel Query on Cytotec Adverse Events Sought

The Tatia Oden French Memorial Foundation asks FDA to conduct a Sentinel query on misoprostol adverse events and consider action to assure patient and...

Human Drugs

Divis Laboratories Inspection Finds API Deviations

FDA warns Indias Divis Laboratories about significant deviations from CGMP for active pharmaceutical ingredients.

Human Drugs

API Deviations Found in Teva Hangzhou Plant

FDA warns Tevas Hangzhou active pharmaceutical ingredient manufacturing facility in Zhejiang, China, about CGMP deviations.

Human Drugs

FDA Acts Against Illegal Cancer Treatments

FDA warns 14 companies about marketing more than 65 products claiming to have anti-cancer properties.

Human Drugs

Emergency Doxycycline Shelf Life Guidance

FDA publishes a draft guidance on criteria and the process for government stakeholders to seek an extension to the expiration date for doxycycline sto...

Federal Register

CDER Site Tours Program to Continue

Federal Register notice: CDER announces its continuation of the Regulatory Project Management Site Tours and Regulatory Interaction program.