The Lachman Blog

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11
Nov

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 […]

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07
Nov
Every Word Counts! Or Does it Image

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 […]

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02
Nov

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 […]

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01
Nov

Revised Guidance on Waivers and Reductions of Fees for Animal Drug Applications is Issued

The Center for Veterinary Medicine has released a revised draft Guidance titled Animal Drug User Fees and Waivers and Reductions, which “describes the types of fees FDA is authorized to collect under ADUFA and how to request waivers and reductions for such fees. It clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures […]

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26
Oct

You Learn Something New Every Day!

The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me.  Turns out that, if you are an ANDA applicant […]

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25
Oct

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 […]

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