FDA Warns A-S Medication Solutions for Inaccurate Drug Listings
The FDA warned A-S Medication Solutions over failures to comply with the Food, Drug & Cosmetic Act’s drug listing requirements, following a May 2016 review. Source: Drug Industry Daily
FDA Seeks Feedback on Proposed Disclosure Studies, Color Additive Rules
The FDA is seeking comment on a proposal to study how advertising disclosure statements and drug promotion affect consumers. Source: Drug Industry Daily
AAM Report Shows Patients Nearly Three Times More Likely to Leave Branded Drugs at the Pharmacy
Patients are 266 percent more likely to not pick up brand-name medications after requesting them at a pharmacy, compared to generic prescriptions, according to the Association for Accessible Medicine’s annual…
Supreme Court to Review the Constitutionality of the PTO’s Inter Partes Review
In a case that may change how drug companies deal with patent infringement cases, the U.S. Supreme Court agreed to consider the constitutionality of the PTO’s inter partes review process,…
FDA Plans Public Workshop to Evaluate Studies of Abuse-Deterrent Opioid Use
The FDA is planning a public workshop in July to evaluate the impact of abuse-deterrent formulations of opioid painkillers, and to find ways to better inform the agency’s regulatory approach,…
Senate Hearing on High Drug Prices Focuses on Increased Generic Competition, Less on R&D Costs
The Senate Health, Education, Labor and Pensions Committee sought to answer basic questions on what is driving drug prices sky high, in a Tuesday hearing ostensibly dedicated to the pharmaceutical…
EC Launches First Price Gouging Investigation into Aspen Pharma
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Source: International Pharmaceutical Regulatory Monitor
CFDA Plans Reforms in Approvals and Clinical Trials Processes
The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual…
Gottlieb Sworn In as FDA Commissioner, Announces End of Hiring Freeze
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and…
QuintilesIMS Report: Drug Spending Growth Slows to 5.8% in 2016
Spending on medicines topped $450 billion in 2016, rising less than half as fast as the industry has seen over the past two years. Source: Generic Line
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