Much like all we do at tax time, we look for anything that might lower our taxes. We look for deductions, charitable gifts, donations, business expenses and do a lot of hope and praying. Well, FDA had a corollary situation when they were looking at how to count and where to place ANDAs in the […]
Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA). CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition. In […]
OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown. Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one […]
Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday. This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report […]
As we previously reported here and here, December receipts are missing from the update, even though the rest of the December metrics have been updated (see below). Well, they are not really missing (other than in the report), they just have not been figured out by FDA, due to the issues associated with the shutdown […]
Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman. Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics. This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space. The panelists described the impact […]
The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting. The Science & Regulatory Team discussed […]
Even with the 35-day government shutdown and the stress that came with it, it appears that OGD has broken the 100 approval action barrier again with what looks like (so far) 102 approval actions posted for January as of February 4th. The data is taken from the FDA All Approvals list here . In the first […]
FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019. The Agency gives the following advice as to how […]
The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status. The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently […]
