FDA Issues Guidance Document on CGT

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,

SaMD (Software as a Medical Device), Medical Device Design Control and the Need for US Guidance

I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”.  This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a lean,

New OGD Director Named!

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 Has Another Banner Month on the Approvals Front – But Still No Word on Receipts!

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.

Gottlieb Opens the Toolbox for Dietary Supplements – Beware the Hammer!

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,

FDA 10th Annual Report on 505(q) Petitions and Stay of Action Petitions Released

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.

December OGD Stats Updated, but Still No ANDA Submission Data

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. 

aamlogo

Are You at the Table, or On the Menu? Shouldn’t That Be an Easy Choice?

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 about the future of GDUFA and BSUFA,

Piggy bank on money concept for business finance, investment and saving

AAM Annual Report on Generic Drug Savings Hits the Street

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.