FDA 2013 Review: what was achieved

The last year was a difficult year for the U.S. Food and Drug Administration. For quite a long time, Republicans and Democrats couldn't agree on a spending plan for the fiscal year 2014, which just started on 1 October. On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. On 1 October, the United States federal government then entered the government shutdown. After that, most FDA drug and device related functions only could have continued when funded through fees. But also before the official shutdown, the FDA had to suffer from budget restrictions. Despite that, a lot of actions were ongoing. Here is a short summary of some selected activities:

Legislation

  • One of the most important legislations which passed the Congress and which was signed by the President was the Drug Quality and Security Act, with the main goal of giving the FDA new authorities in regulating compounding pharmacies.
  • For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Already in 2008, the US FDA opened offices in China to increase the number of GMP Inspections. However, little progress has been made since that time. The US White House has published a statement on December 5th about a new agreement with China. According to a Pharmalot article, the US FDA will now increase its inspection activities.

Guidances

  • About 30 Guidances were drafted or issued. Three of them related to the above mentioned Drug Quality and Security Act. Some of the most relevant are listed here.
  • FDA was also proposing a new regulation to implement administrative detention authority during inspections.

Co-operation with EMA and the European Union

  • The European Medicine Agency (EMA) and the U.S. Food and Drug Agency (FDA) have published a joint question-and-answer document that provides further guidance on the quality-by-design concept.
  • EMA and FDA published a joint report on the pilot program on Quality by Design (QbD) applications.
  • In a Press Release the US FDA announced that the U.S. is now a "listed" country" with the European Commission and does not need to issue Written Confirmations.

Pharmaceutical Development and INDs

  • A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant.
  • FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011.
  • Two new Question and Answer Documents on Investigational Drugs have been published.

Medical Devices

  • The draft of a Question and Answer document entitled "The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers" is new and provides proposals for the use of Good Laboratory Practice (GLP) under research and marketing authorisations for medical devices.
  • The UDI topic (Unique Device Identification) which is a code enabling the unique identification of medical devices has become of high importance for the FDA. In so far, the new provisions on UDI systems were published at the end of September in the Federal Register.
  • The FDA finalised a draft from July 2011 on the question: "Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff".
  • The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) in fiscal year 2013 (199 Warning Letters) has set a new record (181 were issued in 2012). Among the 199 Warning Letters issued in fiscal year 2013, "only" 159 refer to cGMP requirements for medical devices (Quality System Regulations (QSR) in 21 CFR 820).  
  • Since July 2013, cGMP requirements on combination products apply in the USA as per 21 CFR Part 4.

Other important activities

  • The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms, APIs under the Generic Drug User Fee Act.
  • Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has published a list with all DMFs which meet these criteria
  • FDA now offers eLearning for eCTD Implementation and has launched a new service on the website.

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