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Laws and regulations governing the life sciences industry
change almost daily. How can you ensure that your
licensing, distribution, and marketing and sales practices
remain compliant?Distribution: Trade & Sample (Legend Drugs)
Distribution: Trade & Sample (Controlled Substances)
Distribution: Prescription Device
Transparency & Limitations
Mid-level Regulations:Legend Drugs
Mid-level Regulations:Controlled Substances
International Life Sciences TransparencyDatabase
Porzio Compliance Digest (PCD)is the first interactive, Internet-based compliance database on state, federal and global laws,regulations and pending legislationgoverning the distribution of tradeand sample products, sampling tomid-level practitioners andmarketing disclo sures, restric tionsand limitations.
No more tedious Internet searches–a single query searches the laws of all 50 states and the District ofColumbia, federal laws, globalregulations and industry guidancedocuments, retrieving vital detailsto ensure that your team builds acomprehensive compliancestrategy.
Porzio Compliance Digest Databases
Distribution: Trade & Sampleand Prescription DeviceThese databases provide nation -wide statutes, regulations andpending legislation governing acompany’s or repre sentative’sdistribution of trade product andsamples, including prescriptiondrugs (legend and controlledsubstances), and devices. Theydetail federal and state requirementson sampling by representative andmail, alternatives to sampling, salesrepresentative and company regis -tration, licensing and theft/lossreporting.
Transparency & LimitationsOffers in-depth information on lawsand pending legislation regardingmarketing and sales practices andinteractions with healthcare pro -fessionals. This database providescompliance requirements andrestrictions related to marketingactivities, drug price reporting,excessive drug pricing, medicalfacility policies, clinical trials,pharmacy benefit managers andadvertising restrictions.
100 Southgate ParkwayP.O. Box 1997Morristown, NJ 07962-1997Tel: 973.538.1690 [email protected]
About Porzio
For more than 30 years, the law firm of Porzio, Bromberg & Newman P.C.
has provided regulatory counseling, risk management and litigation
avoidance counseling to pharmaceutical, biotechnology and medical device
manufacturers. Our experience and dedication to the life sciences industry
led us to create Porzio Life Sciences.
Call us today to strengthenyour compliance programwith Porzio Compliance Digest.
Mid-level RegulationsPresents legend and controlledsubstance prescriptive andsampling authority for mid-levelpractitioners, including APRNs,physician assistants, direct-entrymidwives, dentists, podiatrists,veterinarians, optometrists andpsychologists.
International Life SciencesTransparency DatabaseContains in-depth information on current global laws, industrycodes, and pending legislation,related to non-US sales andmarket ing practices and inter -actions with healthcareprofessionals.
InfoCenterProvides updates related to our Databases and ComplianceModules. This section of thedatabase details the latest newsrelated to existing laws andpending legislation impact ing thedistribution, marketing and salesactivities of the life sciencesindustry.
Topics include:
• Federal Laws and Bills
• FDA and OIG Guidances and Notices
• Industry Codes of Ethics
• State Laws, Regulations and Bills
• State Advisory Opinions and Proposed Rules
InfoCenter updates are color-codedto differentiate pending fromenacted legislation, allowing usersto quickly grasp the status offeatured topics. Our ResourceCenter supplies links to state andfederal agency websites and othervaluable resources, providing evengreater efficiency for subscribers.
As a one-stop information source,PCD provides a comprehensiveoverview of both the rules andguidances in an ever-changinglandscape of laws, regulations andguidances.
100 Southgate ParkwayP.O. Box 1997Morristown, NJ 07962-1997Tel: 973.538.1690 [email protected]