Porzio Compliance Digest

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

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

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

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.

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 healthcare professionals.

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.

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.

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

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.