The Dynamic Environment of Laws, Regulations and Policy.Coming to Grips with uncertainty in the process

Richard M. Lewis, PhDAccess BIO, LCrlewis@accessbio.com

Or:

What are they thinking?

What do they really want?

What did they mean by that?

Federal Register

Official Government PublicationDaily

Federal RegisterExecutive Orders and ProclamationsRules and RegulationsProposed RulesNotices

Availability of GuidancePublic meetings

The Laws

Order of EnactmentStatute - Congress and ExecutiveRegulations - Executive Agency, FDAGuidance - Agency, CenterSOP - Center

Example: Statute

Food and Drug Administration Modernization Act of 1997To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices and biological products, and for other purposes, Nov. 21, 1997.

Example Regulation21 Code of Federal Regulation

• PART 601 -- LICENSING• Subpart C--Biologics Licensing• Sec. 601.20 Biologics licenses; issuance and conditions.

• (a)Examination--compliance with requirements. A biologics license application shall be approved only upon examination of the product and upon a determination that the product complies with the standards established in the biologics license application and the requirements prescribed in the regulations in this chapter including but not limited to the good manufacturing practice requirements set forth in parts 210, 211, 600, 606, and 820 of this chapter.

• (b)Availability of product. No biologics license shall be issued unless:• (1) The product intended for introduction into interstate commerce is

available for examination, and• (2) Such product is available for inspection during all phases of

manufacture.• [64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]

Example: Guidance• Guidance for Industry: For the

Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products February,1999.

• Guidance for Industry: For the Submission of Chemistry, Manufacturing and Control and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum-Derived Products“ January 21, 1998.

• CBER SOPP, Sections 8400, Marketing

Applications• SOPP 8401: Administrative Processing of

Original Biologics License Applications (BLA) and New Drug Applications (NDA)Effective Date: April 25, 2013

Comment Opportunity for comment for nearly all Regulations and Guidance

http://www.fda.gov/aboutfda/contactfda/commentonregulations/default.htm

Time Form

What’s your product?Where is it regulated?Center and Office differences in policy.

Toxicology

Differences in GMPdrugs v biologics v devices

Office of the Commissioner

Office of Combination Products

Center for Devices and Radiologic

Health

Center for Veterinary Medicine

Center for Biologics

Evaluation and

Research

Center for Food Safety

and Nutrition

Center for Biologics

Evaluation and

Reserach

Public Meetings

Advisory CommitteesJoint IndustryJoint ScientificPart 15

Advisory Committeeshttp://www.fda.gov/AdvisoryCommitteesThere are 50 different FDA advisory committees

Center specificOffice/Product specific

Open to the publicTranscripts Available from FDA (time lag)

Video available commercially.

Public MeetingsPart 15 (21 CFR, Part 15)15.1. The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administration.The FDA has representatives who can ask clarifying questions.

OrganizationsBIODIAPharmaRAPSFDLIAdvaMed

MDMASOTASCO

Organizations

Annual meetingsJoint Workshops

FDA-BIO

Meetings hosted with Industry or Scientific Community

• Usually on a specific issue• Industry Organizations

• BIO

• DIA

• Pharma

• NIH

Services Distribution ListsBIO Smartbrief

DailyRAPS

DailyLinkedIn forums

FDA

Specific Product Reviews

• Clinical• Pharmacology

• CMC• Toxicologic• Statistical• Summary Basis for Approval

EMA Reviews

• EPAR: European Product Assessment Reports• Example: Humira, 243 pages

Product Labels

• What is there• What is not there

Meetings with the FDA

• Pre IND• IND• Pre Phase 3• Pre BLA

Meetings• Type A: (within 30 days of request)

• Necessary for stalled development, e.g., IND on Hold

• Type B: (within 60 days of request)• PreIND, End of Phase 3/pre-phase 3, Pre-

BLA/NDA

• Type C: (within 75 days)All others.

Enforcement

• 483s• warning letters• Untitled letters

Consultants !

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