article thumbnail

The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. See 21 U.S.C. Draft Guidance III.B.2(e)

article thumbnail

From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. They are often overwhelmed by physically and mentally daunting tasks, and the result is often an unpleasant experience for everyone involved. Robotic nurses will help carry this burden in the future.

article thumbnail

Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115