FDA is announcing that it intends to remove all unapproved products containing hydrocodone from the market. The FDA intends to swiftly move against products labeled for use in children under 6 years of age and allow 90-180 days for products not labeled for use in children under 6 years of age.
Manufacturers wishing to market these drugs [...]
Archive for September, 2007
FDA moving against unapproved Hydrocodone products
Published September 28th, 2007 in Events. 0 CommentsCNN ran a story today to increase public awareness that there are hundreds of drugs consumed in the U.S. that have never been formally approved by the FDA. For professionals, the FDA has a web page devoted to this topic. Some of these products were subject to the DESI review process, but it is well known that [...]
PDUFA 2007 - New Submisison Fees for 505(b)(2) Applications
Published September 21st, 2007 Uncategorizedin . 0 CommentsCongress just passed the Food and Drug Administration Amendments Act of 2007. Most of us in 505(b)(2) drug development will think of it as the PDUFA 2007 (Prescription Drug User Fee Amendments of 2007). This amendment covers the period from 2008-2012 (plus, to circumvent the rush experienced with this re-authorization, provisions for an extra 3 [...]
I’ve been teaching 505(b)(2) drug development for almost 3 years now at US, EU and Middle Eastern venues. I was invited to give a short course at the upcoming Drug Re-Positioning Summit in Philadelpia on the morning of October 10 (conference goes thru the 11th).
How to take a day and a half topic and shorten [...]
A source of 505(b)(2) opportunities comes from products that have been discontinued. One of the first things that must be done is to determine why it was discontinued - by law, the product must not have been discontinued for reasons of safety or efficacy. You can check to see if the FDA has made this [...]
Why does Camargo recommend not to use a CMO’s testing lab for development? CMO labs are tailored for commercial production, characterized by many SOP’s and schedules. During early drug development we need answers quickly, sometimes even approximate answers. We’re not bound at this stage by GMPs. We have several outside labs, so we can select one that is [...]
You’re choosing excipients and determining amounts, so you go to the IAG (Inactive Ingredient Guide) look up the approved amounts and you’re good to go. Right?
Maybe not… You need to consider EXPOSURE. Exposure is amount over time. Look at the IAG and determine what products have this excipient/inactive ingredient and compute the potential exposure and [...]
MDS Pharma is back to profitability after shedding its bioanalytical facility in Montreal. This lab conducted analyses of 100’s of bioequivalence studies. FDA audited the lab several times, effectively shut down the lab and called into question the acceptability of the BE study conclusions that were used to approve many ANDA’s. FDA [...]
