Once the drug company gets a letter of approval, the drug company is officially permitted to market the drug. FDA experts review drug advertising and promotional tactics for veracity and fairness. Getting a warning letter from the FDA is no laughing matter. Approximately two weeks after the warning letter is sent to the company, a copy of the warning letter is posted to the FDA website. In most cases, the recipient of the warning letter has corrected the problem cited in the warning letter before the letter is posted to the FDA website.
Recalls are actions taken by a firm to remove a product from the market.
Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Class I recall - situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall - situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. We have surfed the net for years. See our homepage and enjoy what we have found.