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Benefit versus risks: from test tube to patient: improving health through human drugs
APPROVES NEW DRUGS
Under current law, all new drugs need proof that they are effective and safe before
they can be approved for marketing. No drug is absolutely safe . there is always some
risk of an adverse reaction. However, when a proposed drug’s benefits outweigh
known risks, the FDA’s Center for Drug Evaluation and Research (CDER) considers
has a benefit. In the first large clinical
42 days. A 12 percent decline in U.S.
large-scale controlled clinical trials.
a p p roval rule, the Center can rely as a
basis for drug approval on a re a s o n a b l e
s u rrogate endpoint, that is, a positive
e ffect of a drug on a marker of the dis-
ments to physicians and pharm a c i e s .
the actual clinical benefit of the drug.
P romising Experimental Drugs
re s e a rch subjects, the agency ro u t i n e l y
inspects the boards every five years.
may inspect the facilities more often.
especially its safety, and provide treat-
out,’” Temple says. “The sponsor has
final action on new molecular enti-ties, switches from prescription toOTC status, and other important
actions, such as a major new use of adrug. Other approval decisions aremade at the division level.
nearly in half, while the number of
drugs approved in a year have doubled.
sion whether to approve a new drugfor marketing boils down to twoquestions: • Do the results of well-controlled
studies provide substantial evidenceof effectiveness?
P r i o r i t i e s
ity on the basis of the drug’s chemical
disease are considered priority dru g s .
I n d u s t r y and consumer re s p o n s e
division of oncology drug pro d u c t s ;
P D U FA led, in part, to Congre s s ’ s
n a t u r a l l y, go to the office of generic
Outside Advice for Close Calls,” p.
a p p roved decision is a close call.
“ C u rre n t l y, CDER is re v i e w i n g
A Special System for OTC Dru g s
and requested public
FDA’s final monograph, the third phase,
identifies those active ingredients that are
generally recognized as safe and effective
the market as a result of the advisory pan-
els’ OTC drug review. Among them were:
graph identifies labeling claims that may
• camphorated oil, a liniment often acci-
long as it meets its category’s standards.
is deemed safe enough for self-use and is
products can be reformulated or appropri-
ately relabeled. For ingredients or claims
approved solely on the basis of their safe-ty since passage of the 1938 FederalFood, Drug and Cosmetic Act. Specialattention soon focused on OTC drugs: of
Sometimes an approved prescription
the 512 OTC drug products evaluated, 75percent lacked substantial evidence ofeffectiveness.
drug is deemed safe enough for self-
to tackle a broader review of OTCdrugs—no small job, considering thatmore than 300,000 products were on the
use and is switched to OTC status.
market. Those products, however,involved only about 700 active ingredi-ents. It didn’t take long for CDER plannersto decide on a strategy: classify thedrugs by treatment category (antacids,
ingredients. So, rather than review thou-
sands of, say, individual antacid products,
• zirconium, still safe in most forms of
include additional ingredients or to modify
CDER evaluated the far fewer active ingre-
including products used to treat problems
review by publishing final rules within the
for each therapeutic class of drugs under
consideration. The first phase was accom-
recognized as safe and effective for self-
During the second phase, FDA pre s e n t e d
The Evolution of U.S. Drug Law
FDA acts as a public health pro t e c t o r
• Food and Drugs Act (1906)
first drug law re q u i red only that drugs
meet standards of strength and purity.
• Federal Food, Drug and Cosmetic
A bill was introduced in
The "Elixir Sulfanilamide" tragedy of 1937 ensured enact-
ment the following year of the Federal Food, Drug, and
Cosmetic Act. More than 100 died from using the
“Elixir Sulfanilamide” to promote pas-
untested, poisonous new drug formulation, but FDA had
the first time, re q u i red a manufacture r
legal authority to bring only a trivial charge of misbrand-
ing against the manufacture r. The product was labeled an
• D u r h a m - H u m p h rey Amendment
( 1 9 5 1 )
: Until this law, there was no
" e l i x i r," which implied it was an alcoholic solution; actually,
it was a diethylene glycol solution. If the term "solution"
had been used instead, no charge of breaking the law
• K e f a u v e r-Harris Drug
News re p o rt s
• Orphan Drug Act
( 1 9 8 3 ) :
“Orphans” are drugs and
i n t e rest in drug re g u l a t i o n .
eases. They may offer little or no pro f-
about thre e - q u a rters of the cost of
• Drug Price Competition and
The Review Team
A Drug Review Glossary
Abbreviated New Drug
Patient Term Restoration Act
simultaneously apply their special techni-
Application, or ANDA:
( 1 9 8 4 ) :
This law expands the number
of drugs suitable for an abbre v i a t e d
to ensure the identity, strength, quality,
refers to the 17 years of legal pro t e c-
• Pharmacologists evaluate the effects of
tion given a firm for each drug patent.
• Physicians evaluate the results of the
• Generic Drug Enforcement Act
( 1 9 9 2 ) :
This law imposes debarment
A highly spe-
• Pharmacokineticists evaluate the rate
• P rescription Drug User Fee Act
( 1 9 9 2 ) :
In this law, manufacture r s
• Statisticians evaluate the designs for
actual clinical benefit of the drug.
and conclusions of safety and eff e c t i v e-
An official communi-
• M i c robiologists with others evaluate the
data on anti-infectives (antibodies, antivi-
• FDA Modernization Act (1997):
rals, and antifungals). These drugs diff e r
f rom others in that they affect the work-
ings of microbes instead of patients.
n e e d e d to evaluate the drug’s eff e c t i v e-
for the first application for small busi-
F D A’s accelerated approval re g u l a-
track policies and pro c e d u res. In addi-tion, the agency must issue guidance
A panel of
outside experts convened periodicallyto advise CDER on safety and effica-cy issues about drugs. CDER is notbound to take committee recom-mendations but usually does.
Amendment to an NDA:
The finished dosage
Investigational New Drug
Application, or IND:
Rate and extent to
The active ingredi-
Scientific basis on
A drug first investigated
The desired measure
New Drug Application, or NDA:
Good Laboratory Practices, or
FDA guidelines governing the
and, for anti-infectives, microbiology.
New Molecular Entity, or NME:
The rate at which
A chemical synthesized
of time in a given population at risk.
Parallel Track Mechanism:
is evaluated for its biological activities
d rugs for AIDS and other HIV- re l a t e d
“parallel track” protocols, while the
The delivery system
The amount of drug adminis-
The science that
A drug that appears
A marketing applica-
uct that already has an approvedNDA. CDER must approve all
The first trials in humans
Researcher’s records of
the data at the researcher’s office.
Pilot studies to define effi-
The probability of an event
likely to predict therapeutic benefit.
duration of effect during this phase.
the severity of harm that may occur.
A mechanism that
Expanded clinical trials
No drug is completely safe or
lacking the potential for side effects.
ditions of use in the proposed labeling.
Studies performed after a
Safety Update Reports:
Charges to drug firms for
Any effect other than
from drug or nondrug treatment orintervention. Side effects may be
Studies that test
man test systems. Since animals havea much shorter lifespan than humans,
The drug product’s resis-
over an animal’s life cycle and on itsoffspring.
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