From here on out, drugmakers can bet their bottom dollar the sun'll be shining on their financial dealings with doctors and teaching hospitals, but there are still a lot of cobwebs that need to be cleared away as the Physician Payment Sunshine Act goes into effect today.
While the stars are aligning for the makers of medical countermeasures (MCMs), the space still has a lot of black holes as sponsors await more regulatory direction and try to anticipate what a next-generation program might look like.
If the FDA wants innovators to share their risk evaluation and management strategies (REMS) with competitors, it needs to come up with guidance, and possibly incentives, to ensure fair play, a former FDA attorney told the agency Thursday as it kicked off a two-day public meeting on how best to standardize and evaluate REMS.
The FDA's Arthritis Advisory Committee struggled to flip its mind around a broad novel indication of axial spondyloarthritis (axSpA) Tuesday, voting 7-6, with one abstention, to recommend FDA approval of UCB SA's Cimzia to treat active axSpA.
It may be just a jump to the left and then a step to the right, but the time warp that forms between the evolution of clinical science and regulatory science can make the two seem worlds apart.
In what could become a textbook example of putting the cart alongside the horse, the FDA will ask its Arthritis Advisory Committee Monday to consider whether the data are sufficient to make axial spondyloarthritis (SpA), as defined by the Assessment of Spondyloarthritis International Society (ASAS) criteria, a new indication for arthritis drugs.
If a compounding pharmacy looks like a drug manufacturer, walks like a drug manufacturer and quacks like a drug manufacturer, it should be regulated like a drug manufacturer.
The brakes are on India's clinical trials industry as the country implements stiffer regulations in response to outcries that its citizens are being treated like human guinea pigs.
Many of the small biotechs that went public thanks to the Jumpstart Our Business Startups (JOBS) Act "could be left to die on the vine" unless Congress takes additional steps to help emerging growth companies (EGCs) fully access the market, a House subcommittee was told this week.