Products and Services
PORZIO COMPLIANCE DIGEST (PCD)
Comprised of nine distinct Internet-based databases, Regulatory Compliance and Enforcement Action, designed to enable manufacturers, distributors, and labelers to master state and federal laws.
International Life Sciences Transparency Database
In the coming months, Porzio Life Sciences will be introducing its International Life Sciences Transparency Database. This database will contain in-depth information on current laws and codes, and pending legislation, related to sales and marketing practices and interaction with healthcare providers outside the United States.
Specifically, the database will provide information on laws and codes related to transparency reporting requirements, limitations or prohibitions on financial interactions with healthcare providers and organizations, anti-bribery or anti-corruption, data privacy, and company compliance programs regarding interactions with healthcare providers.
Enforcement Action Databases
FDA PDMA Inspections
Information on Established Inspection Reports (EIRs) related to Prescription Drug Marketing Act (PDMA) inspections.
The database catalogues and synthesizes violations noted by FDA inspectors in a searchable format.
Overview of federal actions against life sciences companies that have allegedly violated Anti-Kickback laws, FDA regulations, PDMA or False Claims Act, among others.
The database summarizes compliance requirements of corporate integrity agreements and provides insight into violations most often pursued by the federal government.
OPDP Promotional Violations
Searchable summaries of Untitled and Warning letters issued by FDA’s Office of Prescription Drug Promotion (OPDP), categorized by date of issuance, type of promotional material, identified violation, and other factors.
The database contains copies of issued letters and associated materials, when available, allowing users to assess enforcement trends.
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Regulatory Compliance Databases
Distribution: Trade and Sample - Legend Drug Database
Nationwide statutes, regulations and pending legislation governing distribution of legend drug trade products and drug samples by companies and sales representatives.
The database contains all federal and state requirements on licensing, sales representatives, company registration, and theft/loss reporting.
Distribution: Trade and Sample - Controlled Substance Database
Nationwide statutes, regulations and pending legislation governing distribution of controlled substance trade product, and drug samples by companies and their representatives.
The database contains all federal and state requirements concerning licensing, company and sales representative registration, and theft/loss reporting.
Distribution: Prescription Device Database
Statutes, regulations, and pending legislation governing distribution of prescription devices, such as trade products and samples.
The database includes licensing requirements, storage and handling requirements, record keeping requirements, and theft/loss reporting. It also includes certain aspects of federal device requirements, such as registration, reporting, and device classification.
Transparency and Limitations Database
Current laws and pending legislation on marketing and sales practices and interactions with healthcare professionals.
Topics include gifts to physicians, drug price reporting, clinical trials, pharmacy benefit managers, prescriber data, and direct-to-consumer advertising. The database also includes medical school and healthcare institution interaction policies, as well as, federal legislation, industry codes of conduct, and industry guidance documents.
Mid-level Regulations Legend Drug Database
Statutes, regulations, and pending legislation governing sampling legend drugs to mid-level practitioners for compliance with PDMA and requirements of all 50 states, plus the District of Columbia.
The database provides complete sampling and prescribing authority for 40 classes of mid-level practitioners, plus dentists, podiatrists and veterinarians.
Mid-level Regulations Controlled Substance Database
Statutes, regulations, and pending legislation governing sampling controlled substances to mid-level practitioners for compliance with PDMA and requirements of all 50 states, and the District of Columbia.
The database provides complete sampling and prescribing authority for 40 classes of mid-level practitioners, plus dentists, podiatrists, and veterinarians.
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