Jan. 18, 2017

Vol. 14 No. 11

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FDA Clarifies Annual Reporting Expectations for Wholesale Distributors, Third-Party Logistics Providers

The document addresses questions and comments the agency received on draft guidance. Read More

WHO Recommends 10 Compounds to be Classified as Internationally Restricted Substances

Two synthetic opioids are being proposed for the most restricted class of controlled substances. Read More

Data Integrity, Lab Control Issues Lead to Form 483s for Two Manufacturers

Investigators listed four observations in its review of DLC Laboratories. Read More

NICE Backs UCB’s, Cizma’s Psoriatic Arthritis Drugs

Cimzia and Cosentyx can be used with methotrexate. Read More

FDA Awards Roche’s Tecentriq Priority Review

In 2016, FDA approved Tecentriq for patient with locally advanced or metastatic urothelial carcinoma. Read More