The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States. Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have been trying to apply the PLAIR process to situations for which it was not intended.
Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer. So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th.
To the tune of “Winter Wonderland,” this is “Winter Wonderland,
Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada. The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada. Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements. The supply chain for each drug under a SIP would be limited to three entities,
Without much fanfare, on November 11, 2019, OGD approved the first generic vaginal contraceptive ring. Amneal’s approval showed up today on the Drug@FDA, FDA approved drugs list. It is a therapeutic equivalent to Nuvaring by Organon/Merck. Given the ANDA number, it appears that the application was submitted about early to mid-2018, which by all standards for a complex generic product is somewhat amazing to say the least.
Tomorrow, the FDA will issue a final rule (see prepublication document here) very similar to its proposed rule published in the Federal Register on September 12, 2018.
The notice states “[I]n this final rule, FDA repeals the irradiation regulation, which provided that any drug sterilized by irradiation was a new drug.
Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases. We reported 49 full approval actions and 8 tentative approval actions on December 3rd. With the release of the official November numbers (here), OGD issued 59 full approval actions and 10 tentative approval actions,for a total of 69 approval actions for the month or 4 more than last month (57 full and 8 tentative approval actions).
In a blog post, Kurt Karst (Hyman, Phelps, and McNamara) addressed at least one very significant issue the proposed Blocking Act of 2019 could have (here). Many believe that the change from the current legislative language may erode the value of 180-day exclusivity and, in the long run, could lead to higher drug prices.
The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD. The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”. The conference opened with excellent keynote presentation from Janet Woodcock (Director of FDA’s Center for Drug Evaluation and Research) and David Churchward (Deputy Unit Manager,
N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine (a heartburn medication) has caused nationwide recalls of the products. Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences Authority (HSA) recently announced a recall of several lots of the product in Singapore.
Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives.
Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks. Granted, the backlog of old applications did contribute to the number of approvals but,
Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect. A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”. Since the beginning of time, the Agency has struggled with evaluation of novel excipients in INDs,
We are pleased to announce that John Darby has accepted the position of Senior Director at Lachman Consultants, effective December 2, 2019.
Mr. Darby is a goal directed, results-focused executive professional with a strong, global background in quality assurance, compliance, audits, training, and remediation. His 18 years of experience and keen insight contribute to his ability to identify issues and form innovative solutions and strategies for continued success.