With July in the books and the figures still being posted, we have great news to report. Thus far, as of this morning’s listing in the FDA’s “All Approvals” list (here), the OGD has racked up 97 full approvals (a monthly record by itself for full approvals) and 18 tentative approvals for a total 115 approvals actions,
On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”.
This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller files in additional emails.
In a Federal Register notice today, the FDA announced the outsourcing FY 2019 fees (here) for regular and small business establishment fees and for the reinspection fee. FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019 and will be subject to establishment fees.
A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019. And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years.
The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees.
The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting. The annual BPD fee is assessed the following FY and each year until the sponsor submits a marketing application or until the sponsor notifies the FDA that it is no longer participating in the program;
Back in March 2018, we posted a blog that outlined the FDA actions to remove ANDAs for prescription PEG 3500 (brand Miralax) after a complete RX to OTC switch by the innovator was made. That post can be found here. The story is complex, and it took over 11 years to unfold,
Today, in the Federal Register (here), the FDA announced the FY 2019 Generic Drug User Fees which include application fees, DMF fees and establishment fees for various types of facilities and program fees. While fees for most of the items showed only modest increases, the ANDA and DMF fees increased the most,
As of this morning’s postings on the FDA “All Approvals” report (here), OGD has issued 62 full approvals and 15 tentative approvals. That is a total of 77 approval actions, and we have 8 days of reporting left for the month still.
If the torrid pace of approvals continues for the rest of the month,
Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more. Since February 2018, the FDA has issued sixty-one new guidances and revised forty.
The OGD has indeed been busy but while the industry loves to see the new guidances,
In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.
When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants. FDA has updated its Listing of Patent Disputes (here) through July 13, 2018. This is the first time that we have seen this list (maybe we were asleep at the switch),
FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC). Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable.
Prescription drugs require the intervention of a health care provider, and are typically for products where the patient cannot self-diagnose the condition for which the product is intended.
Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance. The FDA announcement states:
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan,
“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.” 21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption for 100% identity testing for dietary ingredients.
This goes in the “where did this come from?” category. In an earlier post on July 5th where we looked at the available data on the FDA daily approvals and All approvals page for the end of June 2018, we only came up with 67 full and 6 tentative approvals (TAs) actions (see post here).