Newsletter - May 12, 2016
Poorly Structured Survey Misrepresents FDA Approval Process
Over the last few years, FDA has implemented several new pathways to expedite patient access to new drugs, biologics and medical devices. These programs, such as breakthrough designation, Fast Track review, Expedited Access Pathway and Priority Review, have significantly reduced the development and review time for new products. Faster approval adds more pressure on FDA to conduct its review in shorter time and approve products based on partial information. Read More..
Company Wins “Healthy” Label from FDA
Last December, we discussed how the snack bar company, Kind LLC, was first slammed by FDA for using “healthy” on its label and its fight to convince FDA to use current nutritional standards. This week, FDA reversed its decision and allowed the company to use “healthy” label on its packaging in relation to its “corporate philosophy,” not as a nutrient claim. This is a great example of escalating an issue when FDA over-extends its interpretation of the mandate and regulatory intent. Read More..
Poorly Structured Survey Misrepresents FDA Approval Process
Over the last few years, FDA has implemented several new pathways to expedite patient access to new drugs, biologics and medical devices. These programs, such as breakthrough designation, Fast Track review, Expedited Access Pathway and Priority Review, have significantly reduced the development and review time for new products. Faster approval adds more pressure on FDA to conduct its review in shorter time and approve products based on partial information. Read More..
Company Wins “Healthy” Label from FDA
Last December, we discussed how the snack bar company, Kind LLC, was first slammed by FDA for using “healthy” on its label and its fight to convince FDA to use current nutritional standards. This week, FDA reversed its decision and allowed the company to use “healthy” label on its packaging in relation to its “corporate philosophy,” not as a nutrient claim. This is a great example of escalating an issue when FDA over-extends its interpretation of the mandate and regulatory intent. Read More..
