On June 1, 2020, in Docket FDA-2020-N-1127 and published in the Federal Register, the Agency asked for public comment regarding updating and clarifying the types of patents that could be listed in the Orange Book (here). The document sought comments on two specific issues of continued interest: should patents be submitted to the FDA and […]
This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products. In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products […]
In a drug safety communication on September 23, 2020 titled FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class (here), the FDA announced changes being made to the boxed warning on all benzodiazepine products. The communication describes the need for the change as follows: “[T]o address the serious risks of abuse, […]
The history of the issue of the ”intended use” regulations goes back to 2015, as explained in this 39-page pre-publication version of the Federal Register Notice (here), and it is quite an interesting read. The main issue surrounds the notion that, if a firm knows its product is being used for a use not in […]
The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively. This announcement was made on the Federal Register’s […]
The Drug Price Competition and Patent Term Restoration Act of 1984 (better know as Hatch-Waxman) provided a balance between innovation and competition by permitting generic drugs to rely on the safety and efficacy of a previously approved reference listed drug (RLD) rather than unnecessarily repeating duplicative clinical testing to prove what was already known about […]
There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
With ANDA approval, one would expect that market entry would soon follow application approval, right? Wrong! The data suggests that only about 40% of generic drugs approved in any year are actually launched in that year and, after 5 years, there are still about 30% of those products that have still not launched. While this […]
