Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD). Source: Drug Industry Daily

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. Source: Drug Industry Daily

Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Source: Drug Industry Daily

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. Source:…

A Johns Hopkins University panel has released guidelines for prescribing opioids after 20 common surgical procedures, noting that post-op overprescribing been a major driver of the nation’s addiction crisis. Source:…

The FDA shot Signature Formulations a warning letter arising from an October inspection of the manufacturer’s Phoenix, AZ, facility that revealed cleaning and maintenance deficiencies and failure to test products…

Two Democratic senators slammed HHS Secretary Alex Azar for blaming pharmacy benefit managers and drug distributors — and letting manufacturers off the hook — for high drug prices. Source: Drug…

Drug manufacturers set higher prices even when rebates for pharmacy benefit managers decrease, contradicting allegations that rebates may help drive the increases, according to a new report released by the…

PhRMA slammed a new report from the National Governors Association laying out strategies governors are considering to lower drug prices — including the use of value-based pricing, a cap on…

The Justice Department and the Drug Enforcement Administration are proposing a major cut in production of the most commonly abused opioids in 2019. Source: Drug Industry Daily