Category Archives: Legal

Obama Administration Halts Attack on Medicare Drug Plans

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. CMS had issued a proposed rule January 10 to drop “protected” class status for antidepressants and immunosuppressants in […]
Also posted in FDA, healthcare, Market Access | Tagged , , , , , , , | Leave a comment

Obama Budget Takes Slap at Pharma

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.
Also posted in Biotech, IP, R&D, Regulatory | Tagged , , , | Leave a comment

New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
Also posted in FDA, Market Access, People, R&D, Regulatory, Strategy | Tagged , , , , , , | Leave a comment

Merck in Gender Bias Wrangle

Four class representatives have been added to a class-action gender-discrimination employment suit originally filed last May against Merck & Co. in New Jersey.
Posted in Legal | Tagged , , | Leave a comment

Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
Also posted in FDA, Manufacturing, Safety, Supply Chain | Tagged , , , , , , | Leave a comment
  • Categories

  • Meta