With the User Fee negotiations complete, agreed upon by both FDA and industry and proposed bills ready for mark-up, it appears that now the Secretary of the Department of Health and Human Services (DHHS), Tom Price, is requesting that Congress consider raising the negotiated and agreed upon fees to be in line with the Trump budget.
The FDA today announced the addition of 21 new and 16 revisions to existing bioequivalence guidance documents. The Agency continues try to keep ahead of the curve relative to the timing of the issuance of guidance but, at the same time, is making pronouncements for some very old products as well.
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),
With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it looks like the last hurdles have been cleared.
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.
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.
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.
The FDA announced today that it issued Warning Letters to 14 companies for selling unapproved cancer treatments ranging from thermal devices to creams, ointments, syrups, teas, and various pills. Life is too short to have charlatans trying to steal precious chances for life from cancer patients. While I am glad that the FDA has acted,
The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation can be found here.
In comparison to 2015,
The FDA has just updated previous warnings from July 1 and September 21, 2015 (here and here) for use of these two products in children. The new language contains stronger warnings in the form of contraindications for the use of the product in children under the age of 12 and in certain circumstances outlined below for children under the age of 18.
When we look at the number of ANDAs coming into the Office of Generic Drugs (OGD), one might stop to say, how can this be? There has been so much M&A activity in the generic market, some would think that this might be a reason to see the number of submissions decrease or at least ebb,
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,
In the “you learn something new every day” category, I got schooled by my good friend Lisa Parks from AAM this morning. After she read a quote from me pleading ignorance as to why there were so many ANDAs submitted in March, she cleared it up. It appears that March is the end of India’s year,
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.