In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community. The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]
In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here). Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]
CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here). The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise. The FDA says, “the changes increase the number of OND offices that oversee our review divisions from […]
Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]). The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints. Ms. […]
Not wanting to really say we saw this coming, but in a blog post in October 2014 (here), we postulated that the abuse-deterrent aspect of other classes of drugs that have abuse potential would likely be become targets as time passed. In a Federal Register Notice (here), this prediction made in 2014 appears to be […]
Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i]. This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations. In 2016, […]
In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products. The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies […]
For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.” The Q&A guidance contains five questions, along with the Agency’s current thinking on […]
Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]
As I read the article “Prescription-drug policy: Don’t throw the bed out with bedpan”, written by Jim Waters in the Bluegrass Institute (here) about the “Pay-for-Delay issue, I harkened back to a position I took in a very old FTC law suit (that FTC won) and thought – well, someone else gets it! While I […]
