Procedure: MA RenewalCountry: Global ProcedureVersion #: 01/17/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-PhR-SRCategory: Pharmaceuticals/MD&IVDValidity: Lifetime in most countriesCertified by: Vlad Reznikov Copyright: Pattern of USA Inc.
Procedure: Cosmetics MACountry: Global Procedure Version #: 01/15/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-OTH-CMA-SRCategory: OthersValidity: Lifetime or 5-years, or country-specificCertified by: Vlad
Procedure: Ongoing Pharmacovigilance ServiceCountry: Global ProcedureVersion #: 01/23/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-OPS-SRCategory: PharmaceuticalsValidity: AnnualCertified by: Vlad Reznikov Copyright: Pattern of USA Inc.
Procedure: Medical Device RecallCountry: Global Procedure Version #: 01/17/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-DRC-SRCategory: Medical DevicesValidity: Change, withdrawn, or NRA updateCertified
Procedure: Premarket Approval (PMA)Country: United StatesVersion #: 01/15/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: US-MD-PMA-SRCategory: Medical DevicesValidity: Until MA expiration or next updateCertified
Procedure: New Market Authorization Class I-IVCountry: Global ProcedureVersion #: 01/08/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-VI-IV-SRCategory: Medical DevicesValidity: For five years Certified
Procedure: New Market Authorization Class IIICountry: Global ProcedureVersion #: 01/08/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-VIII-SRCategory: Medical DevicesValidity: For 5 years (US),
Procedure: New Market Authorization Class IICountry: Global ProcedureVersion #: 01/08/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-VII-SRCategory: Medical DevicesValidity: For five years Certified
Procedure: New Market Authorization Class ICountry: Global ProcedureVersion #: 01/08/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-VIA-SRCategory: Medical DevicesValidity: Until Change or local
Procedure: The Breakthrough Devices ProgramCountry: United StatesVersion #: 01/18/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: US-MD-BDP-SRCategory: Medical DevicesValidity: Until 510(k), PMA or De
Procedure: Pre-market Notification 510(k)Country: United StatesVersion #: 01/12/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: US-MD-PMN-SRCategory: Medical DevicesValidity: Change, withdrawn, or FDA updateCertified by:
Procedure: Q-Sub Activities Country: Global Procedure Version #: 01/03/2024 Author: Daria Kostiuchenko Editor: Daria Kostiuchenko ID: GP-MD-QSA-SR Category: Medical Devices Validity: Until MA Application Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Q-Submission (Q-Sub) refers to the important opportunities for submitters to share information with NRA and receive input outside of the submission
Procedure: Disinfectants MA Country: Global Procedure Version #: 01/11/2024 Author: Daria Kostiuchenko Editor: Vlad Reznikov ID: GP-DIS-MA-SR Category: Disinfectants Validity: Defined by NRA, until renewal or change Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Disinfectant, including antiseptics requirements and market authorization vary globally, subject to the regulations of individual countries or regions.
Procedure: Food Supplements MA Country: Global ProcedureVersion #: 01/09/2024Author: Maria IvanovaEditor: Vlad Reznikov ID: GP-SUP-MA-SRCategory: SupplementsValidity: Defined by NRA, until renewal or changeCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The global regulation of food supplements involves diverse requirements and market authorization processes, shaped by the distinct regulations of individual countries or regions. This
Procedure: Q-Sub Activities Country: Global ProcedureVersion #: 01/03/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-MD-QSA-SRCategory: Medical DevicesValidity: Until MA ApplicationCertified by: Vlad ReznikovCopyright:
Procedure: Sunset Clause and MA closing activity Country: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-CSR-SRCategory: Pharmaceuticals/MD&IVDValidity: ImmediateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY A sunset clause refers to a regulatory provision that sets a predetermined expiration date or termination point for the marketing authorization of a product. This clause
Procedure: Randomized Labeling for CRO Country: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-RND-SRCategory: Pharmaceuticals/MD&IVDValidity: Upon requestCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY In drug development conducted by Contract Research Organizations (CROs), randomized labeling involves the assignment of unique codes or labels to investigational drug products in a random manner. This
Procedure: Commercial Ad, Labeling and Health Claims Compliance Check Country: Global Procedure Version #: 01/05/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: GP-PhR-CLH-SR Category: Pharmaceuticals/MD&IVD/Others Validity: Until next NRA update Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY A Commercial Ad, Labeling, and Health Claims Compliance Check for healthcare products involves a thorough
Procedure: REMS and ETASU DevelopmentCountry: United StatesVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: US-PhR-RMS-SRCategory: PharmaceuticalsValidity: Next FDA call for actionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The FDA may require Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU) for drugs with specific safety concerns. REMS and ETASU
Procedure: Single Lay User Prototype UI/UX TestingCountry: Global ProcedureVersion #: 01/05/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-MD-PTS-SRCategory: MD&IVD/OthersValidity: NACertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Single Lay User Prototype UI/UX Testing is integral to the success of a healthcare startup developing medical devices. It aligns the design with user needs, identifies potential challenges,
Procedure: Line (MA) Extension Country: Global ProcedureVersion #: 01/04/2024Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: GP-PhR-LXT-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc.
Procedure: Generic Drug (ANDA) New MA Country: Global ProcedureVersion #: 01/04/2024Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-AND-SRCategory: PharmaceuticalsValidity: Reg. 5 YearsCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY Generic products undergo rigorous bioequivalence studies to establish their similarity to the reference listed drug (RLD), affirming pharmaceutical and therapeutic equivalence. The generic drug must exhibit
Procedure: Type II variation approval Country: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VII-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc.
Procedure: Type IB variation notifications Country: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VIB-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc SUMMARY A Type IB variation is characterized as a variation that does
Procedure: Non-clinical data SEND conversionCountry: Global ProcedureVersion #: 01/03/2024Author: Vlad ReznikovEditor: Daria Kostiuchenko ID: GP-PhR-SND-SRCategory: PharmaceuticalsValidity: Until SubmissionCertified by: Vlad ReznikovCopyright: Pattern of USA Inc.
Procedure: CARES Act Reporting Country: United States Version #: 01/03/2024 Author: Vlad Reznikov Editor: Daria Kostiuchenko ID: US-PhR-CRS-SR Category: Pharmaceuticals/Others Validity: Annual Reporting Certified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY The U.S. FDA CDER NextGen Portal Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Reporting initiative streamlines and enhances the reporting process,
Procedure: Type IA and IA-IN variation notificationsCountry: Global ProcedureVersion #: 01/03/2024Author: Mariya IvanovaEditor: Daria Kostiuchenko ID: GP-PhR-VIA-SRCategory: PharmaceuticalsValidity: Until next MA expiration or updateCertified by: Vlad
Procedure: Innovative Drug MA (Novel NDA)Country: Global ProcedureVersion #: 12/07/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-NDA-SRCategory: PharmaceuticalsValidity: Lifetime/5 years/country-specificCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY The New Market Authorization (MA) for Innovative Drug Registration, known as Novel NDA, is a regulatory process facilitating the approval and introduction of new and innovative drugs to the market. This process involves a comprehensive assessment of
Procedure: Investigational IND ApplicationCountry: Global ProcedureVersion #: 12/07/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-IND-SRCategory: PharmaceuticalsValidity: Until MA obtaining or NRA updateCertified by: Vlad Reznikov Copyright: Pattern of USA Inc. SUMMARY The first step of any
Procedure: NRA ClassificationCountry: Global ProcedureVersion #: 11/28/2023Author: Daria KostiuchenkoEditor: Daria Kostiuchenko ID: GP-PhR-CLS-SRCategory: PharmaceuticalsValidity: Until MA obtaining or NRA updateCertified by: Vlad ReznikovCopyright: Pattern of USA Inc. SUMMARY Divergent classification by national regulatory agencies is pivotal for companies to align with the distinct requirements of each target market. In the realm of regulatory affairs, it plays a crucial role