Overview of Drug Development and Regulatory Compliance

Drug Development

Process of bringing new drugs to market.

Preclinical Phase

Initial testing phase before human trials.

IND (Investigational New Drug) Application

Request to FDA to begin clinical trials - first step.

NDA (New Drug Application)

New Drug Application for FDA approval - final step.

BLA (Biologics License Application)

A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.

Post-Marketing Studies

Research conducted after drug approval.

Early Drug Discovery

Initial research phase for new drug candidates.

Preclinical Research

Laboratory and animal testing for safety evaluation.

Good Laboratory Practices (GLP)

Regulations ensuring quality in preclinical studies.

In Vitro Testing

Testing conducted in a controlled environment outside a living organism.

In Vivo Testing

Testing conducted in living organisms.

Toxicity

Potential harm a drug may cause.

Clinical Research

Studies conducted on humans to assess drug safety.

Clinical Research Phases

Different stages of clinical trials for drug evaluation.

FDA Review

Evaluation process for drug approval by FDA.

Drug Absorption

How a drug enters the bloodstream.

Drug Distribution

How a drug spreads throughout the body.

Drug Metabolism

How a drug is processed by the body.

Drug Excretion

How a drug is eliminated from the body.

Dosage

Amount of drug administered to patients.

Mechanisms of Action

How a drug produces its effects.

Adverse Events

Negative side effects experienced from drug use.

Drug Interaction

How a drug affects or is affected by other drugs.

Phase 1

Initial trial phase for dosage and treatment understanding.

Phase 2

Focus on safety with ~300 disease participants.

Phase 3

Evaluate efficacy and side effects with 300-3000 participants.

Phase 4

Long-term monitoring of treatment benefits vs side effects.

Clinical Trial

Research study testing new drugs or treatments.

New Drug Application (NDA)

Application demonstrating drug safety and efficacy.

FDA Review

Examination of submitted drug data for approval.

Labeling

Describes drug use and approval basis.

Regulatory Compliance

Adhering to industry laws and regulations.

Preclinical Research

Studies conducted before human trials begin.

Serious Side Effects

Significant adverse reactions observed during trials.

Controlled Clinical Trials

Studies comparing treatment effects with a control group.

FDA Post-Market Safety Monitoring

Ongoing safety checks after drug market release.

Study Reports Submission

Required documentation after trial completion.

Review Team

FDA group assessing drug application completeness.

Approval Decision Timeline

6 to 10 months for NDA review completion.

Efficacy

Effectiveness of a treatment in achieving desired results.

Dosage

Amount of drug administered to participants.

Monitoring Trials

Ongoing observation for safety and efficacy issues.

Drug Abuse Information

Data regarding potential misuse of the drug.

IRB Compliance

Adherence to Institutional Review Board regulations.

Market Approval

Official permission to sell a drug to the public.

Safety Updates

Revisions to drug information based on new data.

FDA

Primary US body regulating biotechnology products.

FDCA

Federal Food, Drug, and Cosmetic Act regulations.

EMA (European Medicines Agency)

European agency regulating biotechnology products.

PMDA

Japanese regulatory body for pharmaceuticals and devices.

NMPA

Chinese agency overseeing medical products regulation.

Biologics

Includes vaccines, blood products, and gene therapies.

Pharmaceuticals

Drugs produced via biotechnological methods.

Medical Devices

Includes in vitro diagnostics and implantable devices.

Preclinical Research

Approval needed for animal studies.

Clinical Trials

Conducted under Good Clinical Practice standards.

Marketing Authorization

A rigorous process involving submission of extensive data on safety, efficacy, and manufacturing practices. The approval process can be lengthy and involves multiple phases of review.

GLP

Good Laboratory Practice for preclinical studies.

Good Clinical Practice (GCP)

A set of international guidelines that ensure the safety and integrity of clinical trials (ethical principles, informed consent, safety, scientific integrity, risk minimization, quality assurance).

GMP (Good Manufacturing Practices)

Ensures consistent quality in product manufacturing.

GDP

Good Distribution Practice for product handling.

CGMP

Current Good Manufacturing Practice regulations.

CFR (Code of Federal Regulations)

A compilation of the permanent and general rules that govern the United States.

Regulatory Pathways

Processes for product approval and compliance.

Good Manufacturing Practices

System ensuring quality in healthcare product production.

Documentation

Proof of adherence to manufacturing procedures.

Quality Standards

Criteria ensuring safety, potency, and purity.

Regulatory Bodies

Organizations overseeing compliance and safety standards.

CFR

Code of Federal Regulations governing federal rules.

Part

Major division within the CFR chapters.

Subpart

Subdivision of a part in the CFR.

Section

Basic unit of the CFR, detailing specific regulations.

Paragraph

Subdivision within a section for further detail.

CFR Citation

Reference format for locating regulations in the CFR.

21 CFR 211.67(a)

CFR citation for pharmaceutical equipment maintenance.

Title

Numerical identifier for a broad subject area.

Current Good Manufacturing Practice

Regulations ensuring quality in pharmaceutical production.

FDA

U.S. Food and Drug Administration overseeing drug regulations.

Documentation

Records providing traceability of pharmaceutical products.

Standard Operating Procedures

Documented procedures for consistent operational practices.

Batch Records

Records detailing production of specific drug batches.

Test Records

Documentation of testing results for pharmaceutical products.

Specification Forms

Documents outlining product requirements and standards.

Deviation Forms

Records for documenting deviations from standard procedures.

Equipment Cleaning Records

Documentation of cleaning procedures for manufacturing equipment.

Control of Components

Management of materials used in drug production.

Label Controls

Regulations governing labeling accuracy and accountability.

Communication

Process of notifying personnel about procedural changes.

GovInfo

Website for accessing federal regulations and documents.

Training Requirements

Mandated education and experience for pharmaceutical personnel.

Labeling Operations

Processes ensuring correct labeling of pharmaceutical products.

National Drug Code (NDC)

Unique identifier for drugs in the U.S. market.

Contamination Controls

Requirements ensuring product quality, purity, and safety.

Cleaning Procedures

Methods to maintain hygiene and prevent contamination.

Food-Grade Lubricants

Lubricants safe for food contact applications.

Pest Control

Measures to manage pests like insects and rodents.

Air-Quality Monitoring

Tracking air quality to prevent contamination.

High-Purity Water Systems

Systems providing water free from contaminants.

Change Control

Documented process for managing laboratory changes.