(AGENPARL) - Roma, 24 Giugno 2022(AGENPARL) – SILVER SPRING ven 24 giugno 2022
Emerging Technology Program |
Pharmaceutical Quality and Manufacturing |
Oncology Regulatory Expertise and Early Guidance (OREEG) |
Clinical Trials, Drug Development and Approval, Investigational New Drug Development Application (IND), Meetings, Engaging with FDA
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OTC Monographs@FDA |
Over-the-Counter Drug Review |
Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
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Over-the-Counter Drug Review |
Phonetic and Orthographic Computer Analysis (POCA) Program |
Drug Safety; Clinical Trials, Drug Development and Approval |
About CDER Small Business and Industry Assistance |
About FDA and CDER |
About FDA |
About FDA and CDER |
CDER Exclusivity Board |
About FDA and CDER |
CDER Ombudsman |
About FDA and CDER |
Doing Business With FDA |
About FDA and CDER |
Jobs at FDA |
About FDA and CDER |
Biosimilar Development, Review, and Approval |
Biologics, Biosimilars, Biologics License Application (BLA) |
Biosimilar Product Information (FDA-Approved List of Biological Products) |
Biologics, Biosimilars, Biologics License Application (BLA) |
Biosimilars |
Biologics, Biosimilars, Biologics License Application (BLA) |
Biosimilars Action Plan |
Biologics, Biosimilars, Biologics License Application (BLA) |
Bisoimilar Industry Information and Guidance |
Biologics, Biosimilars, Biologics License Application (BLA) |
“Deemed to be a License” Provision of the BPCI Act |
Biologics, Biosimilars, Biologics License Application (BLA) |
Frequently Asked Questions About Therapeutic Biological Products |
Biologics, Biosimilars, Biologics License Application (BLA) |
Therapeutic Biologic Applications (BLA) Approval Information |
Biologics, Biosimilars, Biologics License Application (BLA) |
Transfer of Therapeutic Products to CDER |
Biologics, Biosimilars, Biologics License Application (BLA) |
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations |
Biologics, Biosimilars, Biologics License Application (BLA); Databases |
Biosimilar User Fee Amendments (BsUFA) |
Biologics, Biosimilars, Biologics License Application (BLA); User Fees |
Biomarker Qualification Program |
Clinical Trials, Drug Development and Approval |
Combination Products |
Clinical Trials, Drug Development and Approval |
Clinical Trials and Human Subject Protection |
Clinical Trials, Drug Development and Approval |
Development & Approval Process |
Clinical Trials, Drug Development and Approval |
Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers |
Clinical Trials, Drug Development and Approval |
Drug Development Process |
Clinical Trials, Drug Development and Approval |
The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective |
Clinical Trials, Drug Development and Approval |
Economic Assistance and Incentives for Drug Development |
Clinical Trials, Drug Development and Approval |
Coronavirus (COVID-19) |
Clinical Trials, Drug Development and Approval |
COVID MyStudies Application (App) |
Clinical Trials, Drug Development and Approval |
Frequently Asked Questions on Patents and Exclusivity |
Clinical Trials, Drug Development and Approval |
Real-World Evidence |
Clinical Trials, Drug Development and Approval |
Compliance Actions and Activities |
Compliance, Inspections, Enforcement |
Inspections, Compliance, Enforcement, and Criminal Investigations |
Compliance, Inspections, Enforcement |
Unapproved Drugs |
Compliance, Inspections, Enforcement |
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies |
Compliance, Inspections, Enforcement |
Compounding and the FDA: Questions and Answers |
Compounding |
Compounding Risk Alerts |
Compounding |
Compounding: Inspections, Recalls, and other Actions |
Compounding |
Human Drug Compounding |
Compounding |
Acronyms and Abbreviations Search |
Databases |
Drug Approvals and Databases |
Databases |
Drugs@FDA |
Databases |
FDALabel |
Databases |
Inactive Ingredient Database |
Databases |
National Drug Code Directory |
Databases |
Drug Shortages |
Databases |
Search List of Extended Use Dates to Assist with Drug Shortages |
Databases |
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) |
Databases; Generic Drugs, Abbreviated New Drug Application (ANDA) |
Drug Master File webpage |
Drug Master Files |
Drug Master Files: Guidelines |
Drug Master Files |
Type II DMFs for Active Pharmaceutical Ingredients |
Drug Master Files |
Types of Drug Master Files (DMFs) |
Drug Master Files |
Drug Recalls |
Drug Safety, Recalls |
Drug Safety Communications |
Drug Safety, Recalls |
FDA Adverse Event Reporting System (FAERS) Public Dashboard |
Drug Safety, Recalls |
Medwatch |
Drug Safety, Recalls |
Preventable Adverse Drug Reactions: A Focus on Drug Interactions |
Drug Safety, Recalls |
Risk Evaluation and Mitigation Strategies (REMS) |
Drug Safety, Recalls |
Drug Safety Labeling Changes |
Drug Safety, Recalls; Labeling |
FDA Adverse Event Reporting System (FAERS) Electronic Submissions |
Drug Safety, Recalls; Submissions, Forms, Contacts |
Medwatch Reporting for Industry |
Drug Safety, Recalls; Submissions, Forms, Contacts |
Drug Safety and Availability |
Drug Safety; Databases |
Drug Supply Chain Integrity |
Drug Supply Chain |
Drug Supply Chain Security Act |
Drug Supply Chain |
Verify Wholesale Drug Distributor Licenses |
Drug Supply Chain |
Abbreviated New Drug Application (ANDA) |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Dissolution Methods Database |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
First Generic Drug Approvals |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Generic Drug Research-Related Guidances and Reports |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Generic Drugs: Information for Industry |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Guidance Documents for Generic Drugs (search Generics under topic) |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Guidance for Industry: ANDA Submission – Content and Format of ANDAs |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Orange Book Preface |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Patent Certifications and Suitability Petitions |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Product-Specific Guidances for Generic Drug Development |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Self-Identification of Generic Drug Facilities, Sites and Organizations |
Generic Drugs, Abbreviated New Drug Application (ANDA) |
Pre-ANDA Program |
Generic Drugs, Abbreviated New Drug Application (ANDA); Meetings, Engaging with FDA |
FDA List of Authorized Generic Drugs |
Generic Drugs, Abbreviated New Drug Application (ANDA); New Drug Review, New Drug Application (NDA) |
ANDA Forms and Submissions Requirements |
Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts |
Controlled Correspondence |
Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, Contacts |
GDUFA web-based learning courses |
Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees |
Generic Drug User Fee Amendments (GDUFA) |
Generic Drugs, Abbreviated New Drug Application (ANDA); User Fees |
Export certificates |
Import/Export, Regulatory Affairs, International Programs |
Import and Export of Human Drugs and Biologics |
Import/Export, Regulatory Affairs, International Programs |
Information for Exporters |
Import/Export, Regulatory Affairs, International Programs |
Office of Global Policy and Strategy |
Import/Export, Regulatory Affairs, International Programs |
Office of Regulatory Affairs (ORA) Directory |
Import/Export, Regulatory Affairs, International Programs; Submissions, Forms, Contacts |
Expanded Access: Information for Industry |
Investigational New Drug Application (IND) |
Expedited Programs |
Investigational New Drug Application (IND) |
Exploratory INDs |
Investigational New Drug Application (IND) |
IND Exemptions |
Investigational New Drug Application (IND) |
Investigational New Drug (IND) Application |
Investigational New Drug Application (IND) |
Investigator-Initiated INDs and IND submission procedures |
Investigational New Drug Application (IND) |
Pregnancy and Lactation Labeling (Drugs) Final Rule |
Labeling |
FDA’s Labeling Resources for Human Prescription Drugs |
Labeling |
Table of Pharmacogenomic Biomarkers in Drug Labeling |
Labeling |
Medication Guides |
Labeling; Databases |
Advisory Committees (human drugs) |
Meetings, Engaging with FDA |
Best Practices for Communication Between IND Sponsors and FDA During Drug Development |
Meetings, Engaging with FDA |
Engaging with FDA during New Drug Development CDERLearn Course |
Meetings, Engaging with FDA |
News & Events for Human Drugs |
Meetings, Engaging with FDA; About FDA and CDER |
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry |
Meetings, Engaging with FDA; Generic Drugs, Abbreviated New Drug Application (ANDA) |
Pre-IND Meeting FAQs |
Meetings, Engaging with FDA; Investigational New Drug Application (IND) |
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry |
Meetings, Engaging with FDA; Biologics, Biosimilars, Biologics License Application (BLA) |
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products |
Meetings, Engaging with FDA; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA) |
New Drug Application (NDA) Resources |
New Drug Review, New Drug Application (NDA) |
Pre-IND Consultation Program |
New Drug Review, New Drug Application (NDA) |
Requesting a Pre-Assigned Application number |
New Drug Review, New Drug Application (NDA) |
Coronavirus Treatment Acceleration Program (CTAP) |
New Drug Review, New Drug Application (NDA); Clinical Trials, Drug Development and Approval |
Applications Covered by Section 505(b)2) Guidance for Industry |
New Drug Review, New Drug Application (NDA); Investigational New Drug Application (IND) |
Prescription Drug User Fee Amendments (PDUFA) |
New Drug Review, New Drug Application (NDA); User Fees |
User Fee Waivers, Reduction, and Refunds for Drug and Biological Products – Guidance for Industry |
New Drug Review, New Drug Application (NDA); User Fees |
CDERLearn Course – Bringing OTC to Market *As this course was developed in 2011, parts of it are no longer current * |
Over-the-Counter Drug Review |
Development and Regulation of OTC (Nonprescription) Drugs |
Over-the-Counter Drug Review |
Drug applications for OTC drugs |
Over-the-Counter Drug Review |
OTC Monographs and Rulemaking |
Over-the-Counter Drug Review |
Over-the-Counter (OTC) Drug Monograph Process |
Over-the-Counter Drug Review |
Over-the-Counter Monograph User Fee Program (OMUFA) |
Over-the-Counter Drug Review; User Fees |
BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment |
Pharmaceutical Quality and Manufacturing |
Current Good Manufacturing Practice (CGMP) Regulations |
Pharmaceutical Quality and Manufacturing |
Developing and Manufacturing Drugs Including Biologics |
Pharmaceutical Quality and Manufacturing |
Drug Quality Sampling and Testing Programs |
Pharmaceutical Quality and Manufacturing |
Expiration Dates – Questions and Answers |
Pharmaceutical Quality and Manufacturing |
Facts About CGMPs |
Pharmaceutical Quality and Manufacturing |
Pharmaceutical Quality Resources |
Pharmaceutical Quality and Manufacturing |
Quality Metrics for Drug Manufacturing |
Pharmaceutical Quality and Manufacturing |
Questions and Answers on CGMPs |
Pharmaceutical Quality and Manufacturing |
Questions and Answers on Current Good Manufacturing Practices—Control of Components and Drug Product Containers and Closures |
Pharmaceutical Quality and Manufacturing |
Questions and Answers on Current Good Manufacturing Practices—Production and Process Controls |
Pharmaceutical Quality and Manufacturing |
Report a Product Quality Issue |
Pharmaceutical Quality and Manufacturing |
Manufacturing, Supply Chain, and Drug Inspections: COVID-19 |
Pharmaceutical Quality and Manufacturing; Drug Supply Chain |
Current Good Manufacturing Practice (CGMP) Regulations |
Pharmaceutical Quality and Manufacturing; Regulations, Laws, Guidances |
Office of Prescription Drug Promotion (OPDP) |
Post-Marketing Activities and Promotion |
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) |
Post-Marketing Activities and Promotion |
Postmarket Drug Safety Information for Patients and Providers |
Post-Marketing Activities and Promotion; Drug Safety |
Postmarketing Surveillance Programs |
Post-Marketing Activities and Promotion; Drug Safety |
Developing Products for Rare Diseases and Conditions |
Rare Diseases and Orphan Drugs |
Frequently Asked Questions (FAQ) About Designating an Orphan Product |
Rare Diseases and Orphan Drugs |
Orphan Products Grants Program |
Rare Diseases and Orphan Drugs |
Search Orphan Drug Designations and Approvals |
Rare Diseases and Orphan Drugs |
CDER Direct: Electronic Submissions Portal |
Registration and Listing |
Electronic Drug Registration and Listing Instructions |
Registration and Listing |
Registration and Listing Assistance for Non-Traditional Manufacturers of Hand Sanitizer and Related COVID-19 Drugs |
Registration and Listing |
Drug Establishments Current Registration Site (DECRS Database) |
Registration and Listing; Databases |
Registered Outsourcing Facilities (Compounding) |
Registration and Listing; Databases |
Code of Federal Regulations, Title 21 |
Regulations, Laws, Guidances |
Federal Food Drug & Cosmetic Act |
Regulations, Laws, Guidances |
Laws, Regulations and Guidances |
Regulations, Laws, Guidances |
Newly Added Guidance Documents |
Regulations, Laws, Guidances |
Search for FDA Guidance Documents |
Regulations, Laws, Guidances |
CDER Reports & Budget |
Reports |
Division of Applied Regulatory Science Annual Reports |
Reports |
Drug and Biologic Approval and IND Activity Reports |
Reports |
Fast Track Approvals |
Reports |
GDUFA Science and Research Reports |
Reports |
IND Application Reporting: Safety Reports |
Reports |
NDA and BLA Approvals |
Reports |
NDA and BLA Calendar Year Approvals |
Reports |
Office of Clinical Pharmacology Annual Reports |
Reports |
Office of Generic Drugs Annual Reports |
Reports |
Office of New Drugs Annual Reports |
Reports |
Office of Pharmaceutical Quality Annual Reports |
Reports |
CDER Data Standards Program |
Submissions, Forms, Contacts |
CDER Direct NextGen Collaboration Portal |
Submissions, Forms, Contacts |
CDER Direct NextGen Collaboration Portal FAQs |
Submissions, Forms, Contacts |
Electronic Regulatory Submission and Review |
Submissions, Forms, Contacts |
FDA Forms |
Submissions, Forms, Contacts |
Forms and Submission Requirements |
Submissions, Forms, Contacts |
Office of New Drugs Contacts |
Submissions, Forms, Contacts |
Reorganization of the Office of New Drugs |
Submissions, Forms, Contacts |
Addresses for regulatory submissions |
Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) |
Electronic Common Technical Document (eCTD) |
Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA) |
FDA IND, NDA, ANDA, or Drug Master File Binders |
Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA); Drug Master Files |
CDER SBIA Learn: Respository of Training Resources and Recordings |
Training Resources |
CDERLearn Training and Education |
Training Resources |
Stay Informed with FDA Interactive Media |
Training Resources |
Video and Transcript: FDA/CDER’??s Small Business and Industry Assistance (SBIA) |
Training Resources |
FDA User Fee Programs |
User Fees |
Fonte/Source: http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/search-regulatory-references-drugs