OGD just updated its April 2018 statistics as it does before it reports the next month’s receipts and approvals. You can see all of the updated figures for April here, but there are a few things we think are noteworthy to point out. OGD only refused-to-receive (RTR) five (5) ANDAs in April, which was the lowest […]
A number of years ago, I was reading a blog by Kurt Karst (here), the title of which included “A 505(b)(2) NDA in Search of a Basis for Submission and Approval…” Apart from the interesting details covered in the blog about how a product was received under the 505(b)(2) pathway, it highlighted a trend that […]
The FDA has released its required annual report on 505(q) petitions. Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act. Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has […]
Yesterday, the FDA issued two draft guidance documents titled Development of a Shared System REMS (here) and Waivers of the Single, Shared System REMS Requirement (here). As the names may imply, if a shared system is possible, then that is the way an applicant should go, but if there are insurmountable hurdles to a shared […]
This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission. The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application. As the guidance document notes, […]
The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals. While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly […]
During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures. There are three lifecycle phases: Procedure Design and Development […]
Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.” This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized. For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the […]
A long time ago, I was an expert witness in a pay-for-delay (reverse payment) case where, to me, the facts were clear. The patent settlement meant that the generic product would be assured entry into the market 5 years before the patent expired (can you guess what case that was?). In that case, I thought […]
The FDA is urging manufacturers to stop marketing oral OTC benzocaine products for teething and infants and children younger than 2 years of age. FDA also warns this is not just a problem with younger age groups. The product (which is both available for teething and oral spray product for adults) can trigger methemoglobinemia shortly […]
