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Reg Affairs Final

Fall 2022 1st semester

The FDA does not have to approve brand names. False
The generic names process involves a class stem system. True
Brand names are company owned. True
Which document provides the basis for promotional claims. Package Insert
The FDA requires fair balance statements in promotional claims. True
Which of these is considered misbranding? lack of required info, inconspicuous info, misleading info
Adulterated products can be recalled at the sponsor's discretion. False (it’s FDA’s discretion)
Which of these is not a clinical trials consideration? Market strategy (not safety endpoints, patient population, efficacy endpoints)
Developing uniform drug development standards and license application requirements was a goal of ICH. True
ICH guidance documents can always be used in place of FDA guidance documents. False
Clinical Trials are the central focus of Drug development, Safety and efficacy assessments, FDA review
Clinical Trials Requirements Conducted in accordance with cGCP requirements, with prospectively defined clinical protocol, Patient consent, Review by IRB (Investigational Review Board) or IEC (Independent Ethics Committee) Sponsor, Investigator, IRB, and FDA oversight
Clinical Trial Conduct Adherence to Protocol Protocol = prospectively defined scientific experiment Monitoring by sites, by sponsors, Monitor patient safety FDA has specific IND reporting requirements defined in 21 CFR 312.32 Additional info provided in FDA guidance
Additional Clinical Trial Requirements Applicable trials must be posted to, must be ICH E6 compliant, and CSR (Clinical Study Report) should be submitted to appropriate regulatory agencies
What should be considered when doing Clinical Trials? Number of subjects Patient population Length of trial Primary efficacy endpoints Safety endpoints Safety database requirements Previously approved products Current products under development
Generic Names = not company-owned and unique across the world, globally recognized Who provides generic names? Provided by USAN (United States Adopted Names Council) and INN (International Nonproprietary Names) - work closely together on names Class stem system used for different drug families
How are generic names considered? Proposed names submitted for consideration Info about molecule and disease indication are submitted with the application package Names reviewed for “appropriateness” Claims within the name Similarity to other drugs Cultural issues
Examples of generic names Monoclonal antibodies: Rituximab Trastuzumab Drugs: Lenolidimide Thalidomide Sorafenib Ibrutinib Carfilzomib Bortezomib
Brand Names = proprietary, provided by the company and owned via copyrights and trademarks Chosen by the company and reviewed/approved by FDA, FDA has specific division that reviews names to ensure potential named-based medical errors will be limited, Can be a critical factor in drug recognition, market positioning, and sales
Examples of important brand names: Tylenol Viagra Claritin Harvoni Crestor Nexium Nasonex
Who has oversight and Regulation of Drug Advertising? Advertising is placed under FDA jurisdiction in the Kefauver-Harris Amendments Within FDA, the OPDP (Office of Prescription Drug Promotion) has primary oversight of drug advertising
What document is the basis for Drug Advertising? Basis for drug claims in ads is in the PI (Package Insert) PI provides key scientific data for approved product PI is approved by FDA Changes to PI must be approved by FDA
Who checks claims in Drug Advertising? Advertising/marketing materials must be consistent with data in PI FDA will check claims in marketing materials against PI – including TV, radio, print, online, social media Penalties = warning letters, fines, criminal prosecution, and consent decree
Advertising Requirements Factual info based on data in PI – claims not substantiated by data disallowed, Fair balance in statements – acknowledge “good” and “bad” aspects of drug, No direct comparison to competitor products unless a specific study has been conducted
describe Misbranding False or misleading info Lack of required info Conspicuousness and readability of required information Misleading packaging
Adulteration can occur if product: Contains unapproved comments, Is contaminated with a dangerous substance, Is not manufactured in a GMP environment, Is manufactured in an unapproved facility
How is Adulteration handled? Adulterated products can pose a danger to the public If a product is adulterated, it must be recalled through a specific process and the FDA notified
International Council on Harmonization (ICH) 1980s = Harmonization of regulations started It used to require a different dossier for each country, info was redundant 1990 = Birth of ICH in Belgium ICH guidelines published CTD specifications part of the guidelines
Goal of ICH uniform drug development standards and license application requirements Covers drug dev in US, EU, Japan, and most of world
ICH vs FDA Guidance Usually harmonized, but which to follow? If you plan to only test and market in the US, FDA is fine. If tested and used rest of world, follow ICH International regulators always cite ICH guidance Most countries recognize ICH guidance
Organization of CTD Guidance CTD is part of ICH regulations, ICH guidance has designations, E - Clinical Efficacy - (aka GCP), Q - CMC - quality and mfg (aka GMP), S - Nonclinical - safety and nonclinical (aka GLP), M - Multidisciplinary - catch all for anything not applicable
describe the European Medicines Agency (EMA) EMA is similar to US FDA and has oversight over the EU member states But member states could have additional requirements after following the EMA
what does the European Medicines Agency (EMA) oversee? Oversees 3 main stages of medicinal product life cycle R&D Marketing authorization Post-authorization
what is the European Medicines Agency (EMA) made of? Made of 7 committees + Committee for Human Products for Medicinal Use (CHMP) Pharmacovigilance RIsk Assessment Committee (PRAC) Committee for Orphan Medicinal Products (COMP) Committee for Advanced Therapies (CAT) Paediatric Committee (PDCO)
EU Clinical Trials Directive governs clinical trials in EU, Introduced to harmonize/simplify admin provisions of clinical trials in EU, make easier for sponsors to conduct trials across member states, Will be repealed by Clinical Trials Regulation in 2019 (a similar law)
EU Clinical Trials Directive requires submission of the following: Timing and procedures for IMPDs, CTAs, and Ethics Committee (EC) submissions vary by country Investigational Medicinal Product Dossier (IMPD) = the EU version of the US IND (covers most of the technical documents) Clinical Trials Applications (CTA) in member states must submit CTAs for each state following EU directive and local authorities
what do EU Competent Authorities regulatory agencies for individual countries do? These agencies work with the EMA and under EU Clinical Trials directive They can have additional requirements and review times
What are examples of agencies where products can be developed in individual countries? Medicines and Healthcare products Regulatory Agency (MHRA) - UK National Agency for the Safety of Medicines and Healthcare Products - France Federal Institutes for Drugs and Medical Devices (BfArM) - Germany
examples of other Regulatory Agencies around the world? Health Canada Pharmaceuticals and Medical Devices Agency (Japan) - PMDA Drugs Controller General India (DCGI) Therapeutic Goods Administration (Australia) State Food and Drugs Administration (China)
Where are the International Offices and what are the International FDA Activities? Europe, China, India, Latin America, International Inspections - ie inspecting facilities Requirements for international clinical studies - ie following GMP to ensure approval is successful
International regulatory affairs can be complicated due to: Differences in requirements, Differences in timing, Differences in standards of care, Interpretation of regulations. Logistical hurdles include Language, Culture, Time. International markets can be important for the success of a new drug
Created by: Hamncheese52
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