Generics

14
Nov
Upcoming eCTD Date for Technical Rejection Criteria for Study Data Image

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 […]

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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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