The Government Accountability Office (GAO) issued a 70-page report (here) November 2016 on Drug Compounding, which will keep the pressure up for enforcement of the 2013 Drug Quality and Security Act (DQSA). The lengthy GAO Report is enlightening in that it examines: settings in which drugs are compounded; state laws and enforcement;
On Monday, the Office of Generic Drugs (OGD) updated its report on the activity of the Generic Drug Program to include additional data. As this is the report for the first month of the new fiscal year (2017), any comparative data needs to come from previous fiscal years. The October report adds Refuse-to-Receive (RTR) actions,
FDA has revised its bioequivalence recommendation for cyclobenzaprine hydrochloride extended-release capsules. This revision was based on a petition submitted by the current NDA holder and marketer of the product (here). In that petition, the NDA holder requested that FDA require any ANDA applicant to perform an additional bioequivalence study beside the fasting and fed in-vivo studies that were originally recommended.
On November 30, 2016, the 12th Annual Scrip Awards will be held at the Grosvenor House Hotel, Park Lane, London. Lachman Consultants is proud to be a sponsor of the Executive of the Year category. We would like to congratulate all of the finalists in this category:
- Eliot Forster, CEO of Immunocore
- Mireille Gillings,
Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving. At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while we all have difficult jobs,
In the GDUFA II negotiations, there have been some significant changes in the fee structure. For instance, no facility will pay an establishment fee until it is named in an approved application; CMOs will only pay one-third of the establishment fee when named in an approved application; the prior approval supplement fee has been eliminated;
According to the 2017 Work Plan of the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), OIG plans to evaluate the reliance of hospitals on drug compounding outsourcing facilities. This appears to be an expansion in the FDA oversight responsibilities of the OIG. Large-scale facilities that compound without a patient-specific prescription are regulated under Section 503B of the Food,
We have taken a bit of a break from describing some of the key features of the 341-page Final Rule that issued in February 2016, due to all of the other news that has gotten in the way. This post continues to provide salient sections of the Final Rule and describes their impact. Interestingly, as previously described,
The first month of FY 2017 was about the same as most months in FY 2016. OGD fully approved 54 ANDAs and tentatively approved 16 ANDAs for a total of 70 approval actions to open the 5th year of GDUFA. Complete Response Letters stood at 151 for the month – again on par with what we saw on average last year.
Yesterday, we posted an update on the first-time generic approvals from OGD for FY 2016. At the end of the day (hours after our blog publication), the FDA updated their chart. The number in the chart changed from 70 to 72 but then I noticed my error-the report was for the CALENDAR year not the Fiscal year.
Back in May 2016, we did an update on the number of first generic approvals over the last 3 and one partial fiscal year (FY) since GDUFA’s implementation (here). Well, last week, the Office of Generic Drugs (OGD) published its list of first-time generic approvals for the full 2016 FY and now we can update the table we posted in May.
FDA has announced that study data standards are required for clinical and nonclinical studies that are started after December 17, 2017. FDA notes that it may Refuse-to-File (RTF) NDAs and BLAs or Refuse-to-Receive ANDAs if the data does not conform to the standards outlined in the Guidance for Industry – Providing Regulatory Submissions In Electronic Format — Standardized Study Data and to comply with the outline in this notice which can be found here.
Yesterday, OGD updated the final monthly statistics reported in the Activities Report of the Generic Drug program for FY 2016. While we had many of the activity numbers before, this final update provides additional information relevant to the program.
September 2016 saw the fewest number of Refuse-to-Receive (RTR) actions (9) with a FY 2016 yearly total of 246 with the most RTRs occurring in May 2016 (40).
For a few days now, I have been scanning the FDA Monthly Approvals List (here) for November to keep up with the action at the Office of Generic Drugs (OGD). Searches for approvals for November on this site have come back with the following notice after the report was run –
FDA is finalizing its 2012 Proposed Rule and amending the regulations relative to certain Citizen Petitions. While the revisions mostly pertain to section 505(q) Petitions (originally created under the Food and Drug Administration Amendments Act of 2007 [FDAAA]), the Agency is (in at least one instance) broadening the mandatory certification requirements for certain Petitions. The Rule also amends the regulations to conform to the statutory requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.