Attractive young female scientist and her senior male supervisor looking at the cell colony grown in the petri dish in the life science research laboratory

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,

warning sign Vector

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),

Priority switch button positioned on highest level, white background and green light. Conceptual image for illustration of setting priorities and time management.

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,

triple dollar sign - red stencil text on a paper price tag against rustic wood

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). 

Digital e-healthcare in order to connect patients to medical services via smartphone

The Digital Life

In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology.  Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life choices and generally exempt from,

Front facade of the US Supreme Court building in Washington DC.  Words "EQUAL JUSTICE UNDER LAW" are clearly visible right above the columns. Vivid blue sky with clouds is in background.

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).

positive-line-graph

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,

Shot of a young girl laying on a bed and counting pills

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.  

text write on paper

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,

News and media concept wood letters on wooden background

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. 

Frustrated young businessman pulling his hair, studio shot

Surprise, Surprise – More New ANDA Requirements

Anyone contemplating submitting a drug-device combination product like an autoinjector, prefilled syringe, transdermal patch (yes, transdermal patch), etc., should be prepared to address some of the device regulations or you will likely get a deficiency letter.  (To be perfectly honest, if you get these deficiencies, I think you should push back on the FDA, but that is an individual decision you must make.)

FDA has been asking to address 21 CFR 820.20,