Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products. The two documents, one for compounding pharmacies under Section 503A of the Act (here) and the other that addresses outsourcing facilities under Section 503B of the Act (here) describe FDA’s view of how the issue of compounding essentially […]
ANDA approval actions totaled 66 this month, with 51 full approvals (APs) (a little below the monthly average of 55.7 in year 4 of GDUFA so far) and 15 tentative approvals (TA). Receipts picked up to 79 for the month for the third highest month of this fiscal year (FY) (behind 180 in December and […]
On June 5, 2016 we posted a blog (here) outlining Congressional support for an increase in the number of patients that practitioners can treat for substance abuse with designated medications. Tomorrow, HHS will publish a 112-page Final Rule (here) outlining how the phase in of an increase in the number of patients that a provider […]
In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations. As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory […]
The FDA recently issued a draft Guidance document; entitled “Control of Elemental Impurities in Drug Products”. This document provides guidance in light of the issuance of ICH Q3D Elemental Impurities and USP<232> Elemental Impurities – Limits and USP<233> Elemental Impurities – Procedures. USP <232>. Upon implementation (scheduled Jan 1, 2018), USP<232> and USP<233> will replace […]
FDA’s drug shortage list has a total of 60 drug products in the “currently in shortage” status (see list here). As you can see from the table below, injectable products are leading the list with 46 drug products currently in shortage. The second leading category are solid oral dosage forms and then just a […]
Back in January 2016, we posted a blog that described a revision in the bioequivalence (BE) Guidance for Paliperidone Palmitate extended-release suspension for intramuscular use (here). That draft Guidance revision was dated December 2015, just a few months ago. Now another revision takes its place. Some interesting changes are noted. We reported that the December […]
The Proposed Rule based on the Tentative Final Monograph (TFM) (here) is a 101-page monster that addresses consumer-type hand rubs that are designed to be used without water – generally, what one might think of as “hand sanitizers” (or “consumer antiseptic rubs” as the FDA terms them). The Proposed Rule DOES NOT cover “OTC consumer […]
On June 27, 2016, FDA announced in the Federal Register the issuance of a Technical Reference Document titled “Quality Metrics Technical Conformance Guide”. This Guide is meant to supplement the FDA Guidance titled “Request for Quality Metrics” in that it provides technical recommendations for the submission of quality metrics data called for in the Guidance. […]
As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection. At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law […]
