Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product. One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).
The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today. The ANDA number was listed as 205536. It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013. That is almost six years!
So far, for February 2019, it looks like OGD fully approved 83 ANDAs and tentatively approved 23 ANDAs. Of course, the final official numbers won’t be in for about another week or so, but it looks like another month in the 100’s (OGD total of 100 or greater approval actions was missed only one month so far this FY).
The Office of Generic Drugs issued its 2018 Annual Report, which contains the accomplishments of the generic drug program over the past calendar year. The report (here) provides data on approvals and tentative approvals, as well as other actions that OGD has taken over the year. Included in the report are links to various operational,
Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here). Talk about a controversial proposition! The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business. Why? I am not always clear on the answer to that question, but change is always difficult,
Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs. There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances.
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 addition,
Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2). Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research,
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 ANDAs and tentatively approving twenty-one ANDAs.
In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar. Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) .
The Dietary Supplement Health and Education Act (DSHEA) was passed some 25 years ago and,
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 covers FY 2017.
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 and the inability of FDA to collect user fees during the shutdown period.
Each year, the Association for Accessible Medicines (AAM) publishes its report on generic drug savings (here). The data is based on the independent IQVIA organization’s findings. Some interesting findings in the forty-page report are outlined below:
- 93% of generic prescriptions are filled at $20 or less.
- The average co-pay of for a generic product covered by insurance is $6.06 compared to an average brand co-pay of $40.30.
The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings. As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies.
While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process. It seems that we are not alone!
In remarks made at the November 27th FDA meeting “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions”,