Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “ There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these days .” Below are the 4 drugs. No doubt the...
The story keeps getting stranger by the day. A little recent history can be found here. The US is only 2-3% of their entire market so most pharmacies have already found other supplies, such as Walgreens did a few months ago when things started brewing. Will this soon be a Japanese...
More can be read here as well. The issue goes back to a raid in 2006 of a US warehouse in New Jersey. If the pills were a problem, why were they allowed to continue to ship with allegations that factory test records were falsified. Well I guess this now gives us the answer while the...
The issues at hand goes back to 2006 with deviations from specifications on drugs, and now it is up to the Congress and the FDA once more. Did the FDA knowingly allow suspected drugs to continue to be sold? Ranbaxy makes a lot of different generic drugs and there’s no mention of the ones...
The center of the investigation is whether or not the proper amount of the active ingredient was contained in the product and if the shelf life had been properly labeled according to the standards set forth by the FDA. There are efforts being made to group together on inspections with other countries...