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Aug. 21, 2018

Vol. 17
No. 162


FDA: Guidance on Quality Chewables

The FDA released final guidance Monday on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily. Read More

FDA Finalizes Guidance on Microdose Radiopharmaceutical Diagnostic Drugs

Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Read More

Drugmakers to FDA: Lift Monotherapy Restriction in MDD Guidance

Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD). Read More

FDA Hits Chinese API Manufacturer for Testing Violations

The FDA cited API manufacturer Shandong Zouping Dazhan New Materials after a January inspection of the firm’s Shandong facility revealed significant testing and other violations. Read More