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,
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,
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.
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.
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.
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,
While there is not much new to report in the newly added numbers for certain metrics in the Activities Report of the Generic Drug Program for 2017 (here), there could be some raising of the eyebrows at the number of Complete Response Letters (CRL) issued in February (136), which is the lowest number issued for a given month in FY 2017,
Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application. That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications.
We all know how to reset the clock at daylight savings time (albeit the first morning we may find ourselves a bit behind or ahead). We all know how and when to change our watches when we cross time zones. FDA now needs to find out how to reset the clock on several ANDAs, and possibly a 505(b)(2) application,
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,
Once a vibrant means to bring various changes from a reference listed drug (RLD) to market, the ANDA suitability petition seems to have become the bottom of the totem pole, the last one in line, or a member of the forgotten world. As outlined under section 505(j)(2)(C) of the Federal Food Drug and Cosmetic Act,
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,