Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products.…
The leaders of the House health committee sent letters to three opioid distributors and the Drug Enforcement Administration, following news reports of large numbers of the painkillers being sold in…
Scott Gottlieb was sworn in as FDA commissioner May 11 and has his first full day on the job today. Source: Drug Industry Daily
The Senate HELP Committee on Thursday advanced to the full Senate a bill that would reauthorize FDA user fees through 2022. The vote was 21-2. Source: Drug Industry Daily
Australia’s Therapeutic Goods Administration is proposing to expand its authority to impose sanctions and penalties for non-compliant ads. Source: Drug Industry Daily
The Italian Medicines Agency cited Indian API manufacturer Kores for data integrity and systems security issues. Source: Drug Industry Daily
The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Source: Drug Industry Daily
Scheduling conflicts unrelated to the must-pass FDA user fee reauthorization bill postponed a planned markup Wednesday, but the Senate HELP committee has rescheduled the session for today. Source: Drug Industry…
PhRMA unveiled new criteria for membership, setting higher R&D requirements — and eliminating its associate member level entirely, which included 15 pharmaceutical companies. Source: Drug Industry Daily
The FDA published draft revisions to its blueprint for educating health care providers about extended-release and long-acting opioid painkillers. Source: Drug Industry Daily