Drug Development Process - Part 4 PDF

DRUG DEVELOPMENT PROCESS – Objectives
Part IV
1. FDA review of New Drug Application
2. Post-marketing surveillance study
2 Jul2020
Overview of drug development

FDA review
process
New Drug Application New Drug Application
• NDA tells the full story of a drug
• Its purpose is to demonstrate that a drug is
safe and effective for its intended use in the
population studied
• A drug developer must include everything
about a drug—from preclinical data to Phase 3
trial data—in an NDA
• Developers must include reports on all
studies, data, and analyses
New Drug Application FDA Review

• If the application is complete, the review team has 6 to
• Along with clinical results, developers must 10 months to make a decision on whether to approve
include: the drug.
– Proposed labeling • The process includes the following:
– Safety updates – Each member of the review team conducts a full review of
his or her section of the application.
– Drug abuse information – FDA inspectors travel to clinical study sites to conduct a
– Patent information routine inspection
– Any data from studies that may have been conducted – The project manager assembles all individual reviews and
outside the United States other documents, such as the inspection report, into an
“action package.” This document becomes the record for
– Institutional review board compliance information FDA review
– Directions for use – The review team issues a recommendation, and a senior
FDA official makes a decision.
FDA Approval FDA Advisory Committees
• In cases where FDA determines that a drug has • Sometimes questions arise that require
been shown to be safe and effective for its additional consideration.
intended use, it is then necessary to work with
the applicant to develop and refine prescribing
• In these cases, FDA may organize a meeting of
information. This is referred to as “labeling.” one of its Advisory Committees to get
• Labeling accurately and objectively describes the independent, expert advice and to permit the
basis for approval and how best to use the drug. public to make comments.
• Sometimes FDA requires the developer to • These Advisory Committees include a Patient
address questions based on existing data. Representative that provides input from the
• In other cases, FDA requires additional studies. patient perspective
FDA Post-Market Drug Safety

Supplemental Applications
Monitoring
• Developers must file a supplemental
application if they wish to make any significant
changes from the original NDA.
• Generally, any changes in formulation,
labeling, or dosage strength must be approved
by FDA before they can be made
INDs for Marketed Drugs Manufacturer Inspections
• FDA officials conduct routine inspections of drug
• If sponsors want to further develop an approved manufacturing facilities across the United States, and
drug for a new use, dosage strength, new form, abroad if approved products are manufactured
or different form (such as an injectable or oral overseas.
liquid, as opposed to tablet form), or if they want • Manufacturers may be informed of inspections in
to conduct other clinical research or a post- advance, or the inspections may be unannounced.
market safety study, they would do so under an • Inspections may be routine or caused by a particular
IND problem or concern.
• The purpose of these inspections is to make sure that
developers are following good manufacturer practice.
• FDA can shut down a facility if minimum standards are
not met
Drug Advertising Generic Drugs

• All advertisements, such as product claims or • Generic drugs are comparable to brand name
reminder ads, cannot be false or misleading. drugs and must have the same:
• They must contain truthful information about a – Dosage form
drug’s effectiveness, side effects, and prescribing – Strength
information.
– Safety
• Promotional labeling differs from drug
– Quality
advertisements in the way it is distributed.
Pharmaceutical companies give out brochures or – Performance characteristics
other promotional materials to physicians or – Intended use
consumers. • Generic manufacturers must conduct bio-
• The drug’s prescribing information must equivalence studies and file an Abbreviated New
accompany promotional labeling Drug Application
Reporting Problems Active Surveillance
• FDA has several programs that allow • Under the Sentinel Initiative, FDA is developing a
manufacturers, health professionals, and new national system to more quickly spot
consumers to report problems associated with
approved drugs: possible safety issues.
– MedWatch is a gateway for reporting problems with • The system will use very large existing electronic
medical products (drugs and devices) and learning
about new safety information health databases—like electronic health records
– Medical Product Safety Network (MedSun) monitors systems, administrative and insurance claims
the safety and effectiveness of medical devices databases, and registries—to keep an eye on the
• Generic manufacturers must conduct bio- safety of approved medical products in real time
equivalence studies and file an Abbreviated New
Drug Application • This tool will add to, but not replace, FDA's
existing postmarketing safety assessment tools

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DRUG DEVELOPMENT PROCESS – Objectives

Overview of drug development

New Drug Application FDA Review

FDA Post-Market Drug Safety

Drug Advertising Generic Drugs

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