Amendment to User Fee Legislation to Expedite Some Generics and Suitability Petitions

Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill.  However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective.

The Amendment, which was paired down to remove some of the objectionable and potentially congressionally unpalatable and Agency unworkable issues (like expedited review in 150-days for certain ANDAs subject to drug shortage and where there was limited competition),

New Report, Same Problem? I Am So Confused!

Well ANDA fans, we have been trying to track ANDA approvals and tentative approvals during the month and now the FDA has given us another tool called the FDA Approved Drug Products “All Approvals” report (here) which can be run for a specific month.  In addition, the FDA Approved Drug Products daily listing (here) can now be run for a 7- or 14-day period. 

ANDA Supplements Spike in April

The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly show a spike from past months in FY 2017.

GMP Inspection Deficiency Data Trends for 2016 – Who is Minding the Store?

With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes.

If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues cited as most frequently encountered.

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,

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.