Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal [...]
Is it illegal for audiologists to dispense PSAPs? More broadly – are disruptive technologies also exploding healthcare professionals’ ability to prescribe or recommend to their patients? I [...]
Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.
For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.
Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products. Here are some glimpses into the regulatory behemoth that can make a meal of your [...]
According to FDA medical device guidance – substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]
Understanding FDA tobacco compliance – legal requirements, warnings, advertisements, and other regulatory restrictions
FDA’s tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products “deemed” to be subject to FDA [...]