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.

Heartburn?  Better Read the Label

Millions of people suffer from occasional heartburn and take an Over-the-Counter (OTC) antacid, H2 blocker, or proton pump inhibitor to relieve the symptoms.  But is that always the right thing to do?  The FDA wants to make certain such products are properly used and that the public knows use of these OTC products are not without risk.

The New Fee Paradigm of GDUFA II

As you are well aware, the negotiations for GDUFA II have culminated in the release of the new GDUFA II Goal Letter and has improved (at least on paper) the chances for additional improvement in the speed of generic drug approvals.  The initial overall baseline price tag for GDUFA II (starting on October 1, 2017) will be $493.6 million up from the initial $299 million based for GDUFA I. 

Comparability Protocols – One Age-Old Question Answered

Over the years I have been trying to convince firms that certain changes to approved ANDAs must always be filed as a Prior Approval Supplement (PAS) or, in some cases, these changes may be handled as a Comparability Protocol that is approved in an ANDA.  At the GPhA Fall Technical Conference yesterday, Dr. Lucinda (Cindy) Buhse,

FDA Plans to “NIPP” it in the BUD

The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”.  With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major functional areas to facilitate a lifecycle approach to quality starting from pre-approval to post-product approval for branded and generic drug products;

OGD Director Provides Update on Generic Program at GPhA Fall Technical Conference

There is no doubt that the Office of Generic Drugs (OGD) is receiving more work than it anticipated under the negotiated GDUFA I program.  Dr. Kathleen (Cook) Uhl, Director OGD, noted that OGD received over 5 years of work in the first 4 years of GDUFA I, noting that the Agency anticipated receiving only about 750 ANDAs per year under the first 5 years of the program,

Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?

This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara

If there’s something strange in your neighborhood; Who you gonna call?  If there’s something weird, and it don’t look good; Who you gonna call?  Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on in your neighborhood that’s holding up final ANDA (or 505(b)(2) NDA) approval. 

What is Driving Industry Crazy Lately?

We asked around about what issues were driving firms crazy and these same three issues surfaced most often: 1) getting resolution of compliance status after inspection or re-inspection; 2) getting a straight answer from the Agency; and 3) what to do about maximum daily exposure issues relative to the Inactive Ingredient Database (IID).

Taking each issue in order:

Resolution of Compliance Status

Most of the compliance issues we hear about are after a firm’s inspection or re-inspection where the investigator tells the firm that there are no issues or where there is no 483 issued. 

Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets.  The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in the day than the reference listed drug product (and/or authorized generic).