Archive for October 2018
FDA Warns CustomRX Facility for Cleanroom, Potency Testing
The FDA issued a warning to CustomRX of Wichita, Kansas, for serious deficiencies identified during an inspection of its compounding facility, including inadequate cleanroom conditions and product testing. Source: Drug Industry Daily
Read MoreFDA Cites Vanda for Misleading Website
In a rare warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP), Vanda Pharmaceuticals was cited for failing to include any risk information on the product page of its website. Source: Drug Industry Daily
Read MoreFormer Genentech Employees Charged With Theft of Trade Secrets
Three former Genentech employees were indicted by a federal grand jury for allegedly stealing trade secrets from the San Francisco-based Roche subsidiary, which is pursuing litigation of its own against the ex-staffers. Source: Drug Industry Daily
Read MoreAppeals Court Affirms FDA on Denial of Prescription Generics for Bayer Laxative
A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status. Source: Drug Industry Daily
Read MoreNebraska Drugmaker Cited for Lacking Quality Unit
The FDA hit drug manufacturer Oakmont Products of Lincoln, Nebraska, with a Form 483 for lacking a quality control unit, among other serious deficiencies. Source: Drug Industry Daily
Read MoreFederal Court Echoes PTAB Ruling Invalidating Zytiga Patent
A New Jersey federal court threw out Johnson & Johnson’s patent on a top-selling prostate cancer treatment. Source: Drug Industry Daily
Read MoreMHRA Seeks Industry Input on No-Deal Brexit Provisions
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medicine and medical device regulator on its own. Source: International Pharmaceutical Regulatory Monitor
Read MoreFDA Issues Guidance on Postapproval Changes for Synthetics
The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Source: International Pharmaceutical Regulatory Monitor
Read MoreNervous System Drugs Lag in Development, Approvals: Tufts
Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Source: International Pharmaceutical Regulatory Monitor
Read MoreWhistleblowers Allege AstraZeneca Paid for ‘White-Coat Marketing’
A newly unsealed lawsuit accuses AstraZeneca of using nurses to covertly promote its products, echoing a similar complaint against AbbVie. Source: International Pharmaceutical Regulatory Monitor
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