Ever since the forfeiture provision related to 180-day exclusivity as it relates to the requirement that firms receive approval or tentative approval within 30 months from receipt of an ANDA, there has been some industry confusion regarding the exception of a “change in requirements” and how that might toll the 30-month provision. Kurt Karst provides […]
If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA). With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status. With so much riding on any given inspection, what do you do if problems arise with […]
Friday, FDA announced the first Rx to OTC switch for a topical retinoid to treat acne. Patients will soon be able to obtain Differin Gel 0.1%( the generic name of which is adaplene) as an OTC product in their local pharmacy or grocery store. Is this big news? I think so. Back in October 2013, […]
FDA issued a draft Guidance titled “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn” (here) describing how and what type of changes FDA anticipates ANDA applicants to make in such situations. FDA makes clear in the Guidance that it the Guidance does not have applicability to the FDA’s […]
Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.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 […]
