FDA FDA Says More Orphan Drug Labels Need Pediatrics Info Thomas Sullivan Oct 18, 2019 0 The US Food and Drug Administration (“FDA”) provided a report to Congress, entitled Pediatric Labeling of Orphan Drugs, detailing…
DTC FTC Warns Law Firms About Potentially Deceptive Claims in TV Ads Thomas Sullivan Oct 17, 2019 0 The Federal Trade Commission (“FTC”) sent letters to several law firms and marketing companies, warning them that advertisements…
Opioids OIG Report Concludes that DEA was Slow to Respond to Opioid Diversion… Thomas Sullivan Oct 16, 2019 0 Recently, the Justice Department Office of Inspector General (“OIG”) released a report criticizing the regulatory activities and…
FDA FDA OPDP Issues Warning Letter to Galt Pharmaceuticals Regarding Insomnia… Thomas Sullivan Oct 15, 2019 0 The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) sent a Warning Letter to Galt…
State Policy “Pay for Delay” Legislation Signed in California Thomas Sullivan Oct 14, 2019 0 California Governor Gavin Newsom recently signed three legislative bills into law, all aimed at lowering the cost of prescription…
Compliance When Money and Doritos Don’t Suffice – The Crucial Imperative… Thomas Sullivan Oct 12, 2019 0 The current U.S. opioid epidemic has been branded as “the worst drug crisis in America’s history” and a “man-made plague.” …
FDA FDA ANDA Review and Approval Metrics Improving, But Much Work Remains Thomas Sullivan Oct 11, 2019 0 The US Food and Drug Administration (“FDA”) released quarterly data on two programs intended to increase generic competition and…
Uncategorized FDA OPDP Issues Warning Letter to Metuchen Pharma About ED Drug Advertising Thomas Sullivan Oct 10, 2019 0 Recently, the US Food and Drug Administration Office of Prescription Drug Promotion (“OPDP”) sent a warning letter to Metuchen…
Drug Prices How Are Insurers Treating the $2M Drug, Zolgensma? Thomas Sullivan Oct 9, 2019 0 It has been several months since the United States Food and Drug Administration (FDA) approved Novartis’ gene therapy drug…
Drug Prices Nevada Fines Drug Manufacturers for Failure to Comply with Drug… Thomas Sullivan Oct 8, 2019 0 In early October 2019, the Nevada Department of Health and Human Services sent letters to and levied more than $17 million in…