close-up of a young koala bear (Phascolarctos cinereus) on a tree eating eucalypt leaves.

Data Integrity: A View from Down Under

Following the lead of many of the world’s pharmaceutical regulatory agencies, on April 6, 2017, the Australian Therapeutic Goods Administration (TGA) released a Data Management and Data Integrity (DMDI) policy statement. TGA states that the policy “serves to provide some clarification regarding the TGA’s official position regarding DMDI practices for industry,” but at the same time noting that,

Geotechnical engineer setting up traixial test on soil sample

ICH M10 – Bioanalytical Method Validation – Is Harmony Coming to a Lab Near You Soon?

The 11th annual Workshop on Recent Issues in Bioanalysis (WRIB) has ended in sunny Hollywood, CA.  The WRIB provides an opportunity for both industry and regulators to discuss challenges facing the bioanalytical community in the analysis of both small and large molecules.  This year’s workshop had the largest turnout ever, with approximately 750 attendees from all over the world representing large brand pharmaceutical companies,

Coin stacks with letter dice - Fees

The GDUFA II Program Fee Estimates – Gulp!

Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders.  And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit of a shock to some in the medium and highest tiers. 

FDA

OGD Approvals Look About the Same

According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report of the Generic Drug Program in a few days.

gold number 1

First Time ANDA Approvals Announced for 2017

FDA announced (here) that, so far this CALENDAR year through March 24th,  the Office of Generic Drugs has approved 11 first-time generics. That appears to be a good start for the first three months of the year.  All the first-time approvals can be viewed at the link above.

Remember that not all first approvals will immediately be available in the marketplace. 

Close-up of Machine Gears blue tone ; shot with very shallow depth of field

This Could Make Your Head Spin

Seems like almost every day a new Federal or State law is proposed to deal with drug pricing for both brand and generic pharmaceuticals. .  The latest entries that appear to be making progress through the legislative process are from the states of Washington and Nevada. One can just imagine that there are specific differences in all the state and federal bills floating around,

An Network servers in data room .

GXP Data Flow and Security – FDA’s Looking for Sure!

It’s late, do you know where your data is?  Are you really sure?  Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval?  If the answer to all the above questions is yes, congratulations!  Unfortunately,

Business analysis, calculation of the budget in the design of information related to business

Hey, Wait a Minute Here! Are the UFAs in Danger?

Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews.  Am I seeing this correctly?  Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs negotiated for reauthorization and at the 11th hour,