Regulatory Affairs

29
Nov

Pharmacy Compounding Hits the News Again: Some Key Challenges and Pitfalls

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; communications between and […]

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28
Nov
OGD Updates Additional Metrics In March Stats Image

OGD Updates its October 2016 Report on the Activity of the Generic Drug Program (FY 2017)

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, […]

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27
Nov
Another BE Guidance Revised – This Time, Sprinkle it With Fairy Dust Image

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 […]

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21
Nov

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; […]

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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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