FDA Draft Guidance Tells How To Collect, Label Patient Preference DataSue Darcey
FDA issues new draft guidance documents clarifying how benefit-risk determinations are made, considerations for designing pivotal clinical studiesJonathan S. KahanGerard J. Prud'hommeKelliann H. PayneKristin M. Zielinski
Increasingly, there has been quite a bit of press around lupus treatment in India. This is largely because numbers for people with lupus in India are often overstated.According to the CDC, treatment for lupus includes the drug, hydroxychloroquine which is approved by the FDA by prescription only...
On a state-level, New York has this resource center with guidance and documentation on how to keep the restaurant safe and inspection-ready. Like California, New York runs inspections in each county. New York City has its own restaurant inspection process page with resources for new and existin...
However, understanding the distinct roles of each—strategic guidance versus tactical execution—helps clarify their unique contributions to the testing process. This table illustrates the important differences, making it easier to understand why both documents are necessary and how they work together durin...
ELISA remains the most widespread method for HCP analysis, but it will increasingly be supported by characterization and coverage analysis by MS. Some of our clients have already been required by the FDA and EMA to support their ELISA HCP data with MS data. ...
The MHRA became an individual regulatory member in 2022 due to the UK leaving the EU. Maintaining the UK relationship with ICH and the EU required continued UK implementation of guidance documents, and where existing EU law had referred to specific guidance, these references had also been inserted...
- The CDC pointed to its prior guidance when asked by Reuters what vaccines it will accept. "The CDC considers someone fully vaccinated with any FDA-authorized or approved vaccines and any vaccines that (the World Health Organization) has authorized," spokesperson Kristen ...
FDA has stated drug companies can propose up to 10 suffixes for each new biosimilar. Currently, the licensed biosimilars have gained the unique 4-letter suffix, but the older reference product may not have a suffix, for example; for example: adalimumab (Humira). ...
They designed and built the MAKO Tactile Guidance System -- a robotic arm that assists surgeons perform less invasive, more successful surgeries. The machine not only helps control the surgeon's movement, it can also let them know where it's safe and appropriate to cut. The SolidWorks ...