The GDUFA Fees for FY 2017 that go into effect October 1, 2016 were published today in the Federal Register (FR) (here). There are some interesting observations relative to the changes in the fees. Original ANDA application and Prior Approval Supplement fees dropped by almost $6,000 and $3000, respectively. While the number of ANDAs submitted […]
The integrity of all GxP data used to ensure the quality and efficacy of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. To that point, the MHRA has published a draft version for consultation of a guidance titled “MHRA GxP Data Integrity Definitions and Guidance […]
The issue of sameness of labeling for generic drug products continues to be under scrutiny from both the innovator as well as the law bar. However, from a historical perspective, the concept of carving out certain provisions of labeling covered by exclusivity continues to be an area where the FDA has made only a few […]
The number of Controlled Correspondence (CC) sent to the Office of Generic Drugs (OGD) appears to be rising from year to year since the implementation of GDUFA (see chart below). The numbers in this table were derived from the Activities Report of the Generic Drug Program for the respective Fiscal Years so far under the […]
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 […]
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FDA issued a draft Guidance titled “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn” (here) describing how and what type of changes FDA anticipates ANDA applicants to make in such situations.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Yesterday, FDA issued two draft Guidance documents that address the compounding of essentially commercially available drug products.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 […]
