3 ms·
Many niche drugs have no protection, yet because of the FDA approval process, it doesn't make sense for anyone to try to compete.
by auganov 10y ago
Many niche drugs have no protection, yet because of the FDA approval process, it doesn't make sense for anyone to try to compete.
- HarryHirsch 10y agoCompounding drugs is a non-trivial problem, public safety demands compliance and testing. Not too long ago, there was a rash of deaths (!) from a homoeopathic (!!) belladonna preparation. Turns out, the manufacturer was honest and did use belladonna but had a problem with their dilutions, the distribution was uneven and some of their globuli actually had sufficient atropine to kill an infant. The things were sold as a teething aid. For some hair-raisers, try Chemjobber's "Warning Letter of the Week" category: http://chemjobber.blogspot.com/search/label/warning%20letter%20of%20the%20week http://chemjobber.blogspot.com/search/label/warning%20letter... I don't want to find out what things would look like without adult supervision. You also need to prove equivalence for your preparation, bioavailability depends on the filler composition in your pill.