I believe I understand your viewpoint on most issues in 2025. I've shared on other FDA and UHC related threads that I have a good deal of experience getting medical devices cleared by FDA. It is very frustrating and not efficient. A typical FDA review panel assigned to a new product submission is composed of a manager (usually 5-10 years experience but looking to escape to pharma/med device as a VP of Regulatory), a couple senior reviewers (30-65 yo lifers that got hired by FDA out of school and never left for whatever reason), and a couple junior scientists (the new hires with <5 years experience). Rarely do any of them have industry experience or perspective. They lean hard on testing precedent when it's outdated, but also apply new (more difficult to pass) standards on new products. What's worse is they keep products on the market that were previously approved under old standards and permit companies with old products to piggy back approvals of their products under the old standards. The FDA reviewers consider themselves thoughtful scientists, and often ask for additional studies, experiments, and data that are irrelevant to the product approval or indicated uses. In almost every product submission, there has been a negotiation on sample size and time duration because the FDA has no concern over a product's need on the market or the R&D expenses required for their additional asks. Brisket and thunderlounge took my post as naively supporting big pharma, when the current system favors big pharma over the startups and small companies.