Porzio Compliance Digest

Porzio Compliance Digest is the go-to source for compliance professionals looking for regulatory analysis of global, federal, and state life sciences laws relating to the marketing and sale of pharmaceuticals and medical devices.

The Answers You Need

Updated daily, Porzio Compliance Digest offers the latest information and eliminates the need for time-consuming research. Presented in a user-friendly interface, Porzio Compliance Digest is segmented into multiple databases that together address all areas of regulatory compliance.

Transparency & Limitations

This database includes current U.S. laws, regulations, and pending legislation relating to marketing practices, sales practices, and interactions with health care professionals. Topics include:

  • Aggregate spend disclosure
  • Gift limitations and prohibitions
  • Codes of conduct and compliance programs
  • Representative licensure and registration
  • Pricing transparency

The database also includes medical school and healthcare institution interaction policies, industry codes of conduct, and industry guidance documents.

Distribution: Trade & Sample

These databases include nationwide statutes, regulations, and pending legislation governing the distribution of trade products and samples by a company and its representatives. It details federal and state requirements on:

  • Sampling by representative and mail
  • Alternatives to sampling
  • Sales representative and company registration
  • Licensing and theft/loss reporting

Includes databases for legend drugs, controlled substances, and prescription devices.

International Life Sciences Transparency

This database contains in-depth information on current global laws, industry codes, and pending legislation related to non-U.S. sales and marketing practices and interactions with health care professionals.

HCP Authorities and Restrictions

These databases present prescriptive and sampling authority for physicians and mid-level practitioners, including APRNs, physician assistants, midwives, dentists, podiatrists, veterinarians, optometrists and psychologists.

Includes databases for legend drugs and controlled substances.

FDA Office of Prescription Drug Promotion Promotional Violations

This database contains searchable untitled and warning letters issued to life sciences companies by the FDA’s Office of Prescription Drug Promotion and CBER’s Advertising and Promotional Labeling Branch. It contains a section highlighting letters citing unlawful medical device promotion. The database contains copies of issued letters and associated materials, when available. Subscribers may search for specific letters and related violations, allowing them to assess trends in advertising and promotional labeling enforcement.

FDA PDMA Inspections

This database contains information on Established Inspection Reports related to Prescription Drug Marketing Act inspections, searchable by violation, inspector, and areas of inspection.

Government Prosecutions

This database outlines federal government actions against life sciences companies that have allegedly violated, among other laws, anti-kickback laws, FDA regulations, and the False Claims Act. It includes corporate integrity agreement (CIA) summaries, searchable by CIA year, obligation, alleged violation, risk area, and product type.

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10

Regulatory databases

300

Regulatory updates issued each year

70k

Global regulatory data points

Contact Us

Interested in learning more about how the team of experts at Porzio Life Sciences can help pharmaceutical, medical device and biotechnology organizations master the evolving regulatory environment? Please reach out with any questions.

We look forward to hearing from you.