MaPP Revision for Publication of Drug Product Approval Information

The Manual of Policies and Procedures  (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today.  While it’s     current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014. 

Firm Decides to Remove Opana ER from the Market – What Do I Know?

On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.

During the presentation, I was   asked by one participant what I thought the maker of Opana ER would do. 

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,

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). 

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,