FDA's Transparency + Basics for Industry + FDA Track

AnaMariaVR2

Trusted Information Resource
#1
The US FDA has a new web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. This site has basic information about the regulatory process, including information that is frequently requested by industry.

FDA Basics for Industry

This is part of the agency’s ongoing transparency initiative:
Transparency to Regulated Industry

On January 6, 2011, FDA released a report containing 19 action items and five draft proposals to improve transparency to regulated industry:
Phase III Transparency Report

The agency also has established an online performance program for FDA offices nationwide, it is called:
FDA-TRACK
this program features monthly metrics for more than 100 agency offices & provides insight for the public into the FDA’s decision-making and regulatory activities.

 
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AnaMariaVR2

Trusted Information Resource
#2
:read:More resources related to this topic

FDA Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data; Availability (notice)
https://s3.amazonaws.com/public-inspection.federalregister.gov/2012-02184.pdf

FDA Transparency Initiative
FDA Transparency Initiative Overview

FDA Transparency Blog
http ://fdatransparencyblog. fda .gov/ - DEAD 404 LINK UNLINKED

White House: Transparency and Open Government
http :// www. whitehouse. gov/open/ SURPRISE (IT BEING 2019) - DEAD 404 LINK UNLINKED

Presidential Documents, Freedom of Information
http://www.gpo.gov/fdsys/pkg/FR-2009-01-26/pdf/E9-1773.pdf

HHS Open Government
Open Government at HHS
 
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AnaMariaVR2

Trusted Information Resource
#3
On January 31st, 2012 the Trasparency Task Force (part of FDA?s Transparency Initiative) reissue a report titled: FDA TRANSPARENCY INITIATIVE: EXPLORATORY PROGRAM TO INCREASE ACCESS TO THE AGENCY?S COMPLIANCE AND ENFORCEMENT DATA.
http :// www. fda .gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM289490.pdf - DEAD 404 LINK UNLINKED

Eight initiatives are listed as:
-Draft Proposal 1: Improve data quality and timely data disclosure​

-Draft Proposal 2: Facilitate easier reporting and compliance tools​

-Draft Proposal 3: Presentation of data in better graphical formats​

-Draft Proposal 4: Better consolidation and presentation of compliance and enforcement data​

-Draft Proposal 5: More sophisticated and user friendly search tools​

-Draft Proposal 6: Post additional data compilations or analysis to better inform compliance efforts​

-Draft Proposal 7: Better utilization of social media and outreach tools to better inform industry and the public of compliance and enforcement efforts​

-Draft Proposal 8: Provide more context for compliance and enforcement data to make sure data is not misinterpreted​

...draft proposals focus on making available & user-friendly FDA's compliance & enforcement data as they increase transparency on their operations & decision-making in order to better explain their own actions.

Still, the agency has not provided any details on how often or with which depth will explore these initiatives nor how likely these initiatives will go into effect...as we understand today.

In the development of these proposals, FDA has its own definition of "trade secret" & uses this definition to decide which information could be disclosed. This has raised some concerns for FDA-regulated life-sciences companies (mainly, drug & medical device companies)...as there is the potential that information which until now was considered trade secret and/or confidential/proprietary could be subject to disclosure by the FDA.

The proposals fall into these categories:
  1. Adverse Event Reports
  2. Enforcement Priorities & Actions
  3. Imports
  4. Inspections
  5. Recalls
  6. Warning/Untitled Letters
As greater transparency comes together with a greater expectation from the agency...I was wondering if the agency has started to :whip:test the waters & wanted to check with this group:
  • How are these transparency initiatives impacting your operations or your company?
  • Have you seen a surge of inspections picking up in the last year?
  • Are there any common challenges or concerns about them?
  • How is transparency, enforcement & accountability will be managed?
  • Is there a common theme on the type of inspections or enforcement actions?
I look forward to your comments or stories.

Thanks again in advance:thanks:
 
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M

MIREGMGR

#4
> How are these transparency initiatives impacting your operations or your company?

No specifically attributable impact so far.

> Have you seen a surge of inspections picking up in the last year?

No.

> Are there any common challenges or concerns about them?

No opinion. I saw the original announcement, but I hadn't noticed any related action and had assumed that the program had been discontinued.

> How is transparency, enforcement & accountability will be managed?

I know that these areas of FDA operations are regarded as problematic by some, but I don't have any problem with the current FDA approach to any of them, other than their insufficient inspection resources and weak system of penalties and related actions.

My primary concerns with FDA have to do with poorly constructed regulations... mostly related to legacy issues... and with slow progress on harmonization, though in fairness there is a program in place and what I regard as slow progress may simply indicate that I'm impatient.

> Is there a common theme on the type of inspections or enforcement actions?

No opinion.
 
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