Historical aspects of drug approval process

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Historical Aspects
of
New Drug Approval Process
Prepared by:
Paresh K Bharodiya
Executive
Formulation Development
J.B Chem...

New drug Approval.
• Today, the drug review process in the United States is
recognized worldwide as the gold standard. Dru...

Overview of the drug approval process
• Drug development can generally be divided
into phases.
1.The Preclinical phase
2.C...

subjects
Purpose
Time
corse
New
drugs
pass
Laboratory
&
Animal study
Access safety &
Biological activity
1-2 years
100 %
2...

FDA Review and Approval
• After phase III, the pharmaceutical company
prepares reports on all studies conducted on
the dru...

A Historical Perspective of drug
regulation and approval
• At the turn of the 20th century, there were no
federal regulati...

The First Federal Drug Law
• The original Pure Food and Drugs Act was passed by
Congress in 1906 and signed by President T...

• There was no requirement that any information be
submitted to the FDA before marketing
• the law required only that drug...

Sherley Amendment in 1912
• US v Johnson case
• The act did not prohibit false therapeutic claims,
only false claims about...

The Food, Drug, and Cosmetic Act 1938
• Revised legislation wasn't passed until 107 people
died from a poisonous ingredien...

1. manufacturers were required to show that a drug was
safe before it could be marketed.
2. Manufacturers had to submit an...

Durham-Humphrey Amendment, In 1951
• Following the 1938 Act, the FDA began to distribute
public notices (known as trade co...

The DH amendments gave FDA the
responsibility to clarify which drugs are:
• Habit-forming,
• Not safe except under a pract...

The Kefauver-Harris Drug Amendments
• In 1961, an Australian obstetrician, William McBride, reported an
increase of fetal ...

As per The Kefauver-Harris Drug Amendments
1. Before marketing a drug, firms now had to prove not
only safety, but also pr...

• In 1981,
1.formal standards for the Protection of
Human Subjects and
2. Institutional Review Boards (IRBs) were
strength...

Anti-Tampering Regulations 1982
• After seven people in Chicago died from
swallowing Tylenol capsules laced with
cyanide, ...

1983 - “Orphan Drug Act
• the Orphan Drug Act (ODA) was passed in 1983
• It allowed the FDA to encourage research and
deve...

Encouraging Generic Drugs
1984 - “Drug Price Competition
and Patent Term Restoration Act’’
• Expanded the number of drugs ...

Drugs for Life-Threatening Illnesses
• In 1987, partially in response to the human
immunodeficiency virus (HIV) epidemic, ...

The Prescription Drug User Fee Act
• The Prescription Drug User Fee Act (PDUFA)
was passed in 1992, and mandated that drug...

The Food and Drug Modernization
Act of 1997
• In 1997, the PDUFA was renewed under the
Food and Drug Administration Modern...

Expanding Demographics
in Clinical Trials
• In the 1980s and 1990s, several FDA guidance's and
rules drew attention to the...

1. In 1989, the FDA issued guidelines asking manufacturers to determine
whether a drug is likely to have significant use i...

References
1. US Food and drug administration.“Histories
of Product Regulation” , available at http:/
www.fda.gov . Access...

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