I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by […]
It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection […]
The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here). So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY). OGD did say there would be good and bad months for approvals […]
There has been a spate of blog posts on our site regarding dietary supplements and yet again today we are addressing a newly issued revised draft Guidance, entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (here). FDA notes that, under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 […]
The dietary supplement industry has been burgeoning since the 1990’s when the number of products on the US market was approximately 4,000. In 2015, the journal Drug Testing and Analysis estimated the number of US manufacturers to be approximately 15,000, accounting for more than 90,000 products and a $40-billion-dollar industry. The Lachman blog has extensively […]
In early August 2016, FDA issued a Guidance document for “Insanitary Conditions at Compounding Facilities” that states that under Section 501(a)(2)(A) of the FD&C Act that any drug prepared under insanitary conditions is adulterated. This document defines a drug as any compounded human or animal drugs; repackaged drug products; compounded or repackaged radiopharmaceuticals; and mixed, […]
In a pre-publication Federal Register Notice on Friday, August 5, 2016, FDA announced the reopening of the comment period on the issue of OTC Monograph User fees until October 6, 2016. In addition, the Notice indicated that the FDA “will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be […]
Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers. Some metrics have only been reported in the same context for the last […]
Take a look at the wrist of many individuals today and you will likely see a device monitoring physical activity. Whether it be a stand-alone device or one in the form of a watch which also facilitates telephone and text conversations, the business of personal wellness is growing. In 2014, Price Waterhouse estimated that over […]
