A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA and HHS have done all they can administratively to curb drug shortages and now need additional help from Congress, HHS Secretary Kathleen Sebelius told lawmakers Feb. 15. The health chief told the Senate Finance Committee the FDA would strongly benefit from pending bills, S. 296 and H.R. 2245, that would mandate six months notification by drugmakers discontinuing, interrupting or adjusting manufacture of a drug known to be in short supply. Generic Line