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Porzio Compliance Digest (PCD)

PORZIO COMPLIANCE DIGEST (PCD) Porzio Compliance Digest Comprised of ten 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

Enforcement Action Database

Regulatory Compliance Database

 

International Life Sciences Transparency Database

Porzio Compliance Digest: International Life Sciences Transparency DatabaseContains in-depth information on current global laws, industry codes, and pending legislation, related to non-US sales and marketing practices and interactions with healthcare professionals.


Enforcement Action Databases

Porzio Compliance Digest - 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.       
  

Government Prosecutions

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

Map Interface: Porzio Compliance Digest is very easy to use. The system features a user-friendly interface (pictured below) that allows users to easily search for regulations in all 50 states—in seconds! Please contact us to schedule a demonstration.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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