It’s Official – OGD Sets Record for Approval Actions

In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the highest total of total approval actions (100) in a month,

By My Count, A New OGD Approval Record Set in June

With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017.  From data gathered from the daily approval report, I find at least 84 full ANDA approvals,

Enforcement Date Rolled Back One Year for Elements of Drug Supply Chain Security Act

FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers  The guidance explains what a product identifier is and how enforcement discretion will be applied.

Revised MaPP Gives GPS Directions for Priority Review of ANDAs and Supplements and Provides List of FDA Products Without Competition

Revision 3 of Manual of Policies and Procedures (MaPP) 5240.3 was published today and provides an update to include priority review for ANDAs for which there are fewer than three generic competitors.  The MaPP also provides boundaries around when an ANDA will be eligible for priority review by providing a more specific set of conditions,

MaPP Undergoes First Revision Since 2006

The Office of Generic Drugs (OGD) has issued a revised Manual of Policies and Procedures (MaPP) updating the new organizational structure and defining where in the CDER and FDA organization reviews of bioequivalence studies with clinical endpoints will be conducted.  The MaPP, 5210.4, Rev. 2, makes one thing clear, and that is that the initial review and final sign-off on a biostudy with clinical endpoints will now be conducted within the OGD’s Office of Bioequivalence,

Body Building Dietary Supplement Manufacturers –  FDA Says, Watch Out!

While I have never been a big fan of dietary supplements, far be it for me to criticize the entire dietary supplement industry.  Clearly there are people that have clinically documented vitamin deficiencies and require supplementation as a result.   There are also certain disease states where dietary supplementation is definitively indicated.  And, like those of us who rush out to get a Vitamin C supplement at the first sign of a cold (including myself),

Pre-Submission Facility Correspondence for Priority Submissions – Guidance for Industry

The FDA has published guidance for the submission of facility information that is required to assure the shorter review timeframe for priority submissions.  This is a new provision of the GDUFA II negotiation and appears in the Commitment Letter. This pre-submission must be into OGD 2 months prior to submission of the priority application, supplement,

CBO Costs Out New GDUFA II Program

The Congressional Budget Office (CBO) has scored (costed out) additional costs for the provisions of GDUFA II reauthorization over and above the $493.6 million/year (GDUFA II first year fee collection).

The CBO speaks about the additional costs for the new amendments added to GDUFA II, which are believed to be over the fee collection under the program (albeit not clear). 

Timing of Notice, the Patent Dance, and the Supreme Court Ruling

As reported by FiercePharma here, the Supreme Court sided with biosimilar makers regarding the timing of notice to the innovator and agreed that the notice can be accomplished prior to FDA approval of the biosimilar application.  Early notice could provide biosimilar applicants up to a 180-day earlier launch, meaning (obviously) a potentially earlier market entry (should everything go in their favor).

A Banner Month for OGD Approvals

The month of May 2017 may go down as the true turning point in the Office of Generic Drugs (OGD) review and approval process.  If not, it will at least go down as the second highest number of approval actions in a single month since the start of the GDUFA program.  OGD reported fully approving 77 ANDAs and tentatively approving 19 ANDAs for a total of 96 approval actions,

FDA Requests Opana ER Be Removed From the Market.  Will They Fight or Switch?

In what (I believe) is only the second opioid that FDA is seeking to remove from the market because the risk no longer outweighs the benefits of the product (first was the original formulation of Oxycontin), the Agency said “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.  

High Risk Drug Domestic and Foreign Drug Inspections – Get Ready!

After slogging through some of the FDA dashboards, I came across one that I felt was worthy of mention.  The FDA’s Office of Regulatory Affairs (ORA) has apparently begun the process of scoring drug manufacturing establishments in their risk-based inspection program.  The FDA has been talking about risk-based inspection (as well as risk-based review) ever since I was at the Agency,

OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits

The Office of Generic Drugs (OGD) has provided additional updates to its April 2017 metrics, as reported in the above-referenced document.  Not much excitement there but notable for another low month of Refuse-to-Receive (8), which should be good news to industry.  In addition, Drug Master File (DMF) reviews hit a low for this fiscal year at 44.