Another BE Guidance Revised – This Time, Sprinkle it With Fairy Dust!

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. 

12th Annual Scrip Awards

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,

This Turkey Wants to Wish You a Happy Thanksgiving

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,

Alert -Alert -Alert-Annual Program Fee Coming for GDUFA II – You Better be Ready!

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;

Another Worry for Compounding Pharmacies – The OIG Plans to Take a Look At Them!

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,

OGD Releases October 2016 Statistics

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.

Upcoming eCTD Date for Technical Rejection Criteria for Study Data

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.

Activities Report of the Generic Drug Program Final FY 2016

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).  

Every Word Counts! Or Does it?

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.

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