Pharmaceutical Industry Drug Regulatory Affairs (DRA)

Explore regulatory documents required for market authorization, including IND, NDA, and CTD, and learn how the FDA reviews safety, efficacy, and manufacturing data.

The FDA review team evaluates NDA and IND submissions, weighing benefits against risks, uses accelerated approval for life-saving drugs, and issues response letters or seeks advisory input.

Explore the European Medicines Agency's three marketing authorisation procedures—centralised, decentralised, and mutual recognition—and how they enable EU and EEA market access. Understand timelines and processes, including centralised authorisation in approximately 210 days, mutual recognition in approximately 390 days, the role of reference member states, and CHP review.

Review the European Union application submission and review procedure, detailing CHP and PRAC assessments, risk management plan review, clock stops, sponsor questionnaires, and the day 210 market authorization decision.

As the regulatory affairs manager for a new drug, assess national and international markets, align with ICH standards, and plan additional testing, toxicological evaluations, pharmaceutical data, and costs.

Learn how generic drugs match innovator medicines in quality, dosage, and safety while offering 80% to 85% cheaper through the FDA's abbreviated ANDA pathway and bioequivalence standards.

Explore orphan drugs and the incentives that drive market authorization for rare diseases, including US and EU designation processes and benefits like tax credits and seven years of exclusivity.

Explore the Orange Book's role in evaluating therapeutic equivalence of approved generics, its five sections, online access since 2007, and its exclusion of biological products.

The purple book is an online database of FDA approved biological products and their interchangeable counterparts, merging CDER and CBER lists to clarify reference products, biosimilars, and interchangeable designation.

The lecture outlines the green book, a veterinary drug compendium with eight sections on approvals, ingredients, patents, exclusivity, hearings, withdrawals, petitions, and updates, plus three approval paths: nada, anada, canada.

Explore how medical devices are regulated by the FDA, requiring device and facility registration, premarket review via PMA or 510(k) routes, postmarket requirements, and class-based safety standards I–III.

Explore FDA market authorization options for medical devices, including PMA and 510(k) pathways, de novo routes, and post-market considerations for safety, effectiveness, and regulatory compliance.

Learn how the FDA monitors medical devices after approval through postmarket requirements and surveillance methods, including medical device reporting, the Medical Product Safety Network, post-approval studies, and device tracking.

Analyze a case where the FDA's letter prompts removal of an intended use from a drug label, evaluate justified actions, and decide on clinical trials or market research.

Explore good clinical practice (GCP) principles that safeguard participant rights, safety, and data integrity throughout trial planning, execution, and reporting, and understand the responsibility of sponsors, investigators, and ethics committees.

Learn how good laboratory practices safeguard the quality and integrity of nonclinical laboratory studies by ensuring traceable data, proper documentation, and disciplined planning, monitoring, recording, reporting, and archiving.

Learn the core good laboratory practices, from qualified personnel and independent quality assurance to controlled facilities, calibrated equipment, and documented procedures aligned with FDA standards.

Explore GLP principles for reagents and solutions, emphasizing QA testing, proper labeling and storage, and expiration rules; learn record retention, archiving, and FDA inspection processes.

Explore good manufacturing practices (GMP) to ensure medicine quality and safety, detailing organization and personnel, buildings and facilities, equipment, cleaning and maintenance, and control of components and containers.

Explore the remaining good manufacturing practices, including production controls, packaging and labeling, intake and distribution, lab controls, and record-keeping to ensure pharmaceutical safety and quality.

Manage a repurposed drug case by conducting new GLP-compliant toxicology studies and efficacy data to prove safety and effectiveness for the new disease, as the FDA requires.

Explore the drug development lifecycle from discovery to commercialization, including nonclinical and clinical testing, IND and FDA review, phase 1–3 trials, and lifecycle strategies.