At the Association for Accesible Medicines (AAM) CMC workshop last week, the issue of first cycle was on a lot of people’s minds. Industry and FDA realize that the only real way to cut down on FDA workload is to get it right the first time. Industry continues to say with the constantly changing requirements […]
Anyone contemplating submitting a drug-device combination product like an autoinjector, prefilled syringe, transdermal patch (yes, transdermal patch), etc., should be prepared to address some of the device regulations or you will likely get a deficiency letter. (To be perfectly honest, if you get these deficiencies, I think you should push back on the FDA, but […]
Well, things do change in Washington these days on a minute by minute basis and the news cycle continues to amaze even the most skeptical of viewers. Seems like the User Fee Reauthorization is back on track after the House Energy and Commerce Subcommittee rejects the call of the Secretary of HHS to reopen […]
On April 27, 2017, Linda Evans O’Connor, Head of Business Processes and Regulatory, presented at the 2nd Healthcare Asia Pacific Summit 2017 in Singapore. She presented on international regulatory trends, FDA enforcement actions for foreign and domestic firms, the new US Administration and effect on expected guidances, and quality culture.
With the User Fee negotiations complete, agreed upon by both FDA and industry and proposed bills ready for mark-up, it appears that now the Secretary of the Department of Health and Human Services (DHHS), Tom Price, is requesting that Congress consider raising the negotiated and agreed upon fees to be in line with the Trump […]
The FDA today announced the addition of 21 new and 16 revisions to existing bioequivalence guidance documents. The Agency continues try to keep ahead of the curve relative to the timing of the issuance of guidance but, at the same time, is making pronouncements for some very old products as well. For instance, the Agency […]
Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill. However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective. The Amendment, which was paired […]
With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it […]
We were pretty close on our estimates from a day ago (see previous post here). The good thing to take away from yesterday’s post is we now know that the “All Approvals” report (here) and the OGD report of approvals and tentative approvals are now in sync. In April, OGD approved 56 full new ANDAs […]
Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month. In addition, the FDA Approved Drug Products daily listing (here) can […]
