Even diagnostics together with therapeutics should allow for

Even though we belong
to the same specie we are not designed in the same manner when it comes to
genetic level. the 3 billion base pairs present in us are responsible for
20,000-25,000 protein coding genes. And as a result of this we need to group
the population based upon some similarities and dissimilarities. In order for a
personalized medicine to work on a selected group of population or individual
we have to first know if this is the right drug for the right person. And to do
that we need a reliable diagnostic test which gives a low number of false
positive or false negative results. since a diagnostic test is the very first
approach in determining if an individual has a problem or not. it needs to be
constantly updated and monitored. This job is being done by the FDA’s medical
device authority.

They check the
values of the devices based on 

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·     
Analytical
validity:- specific test is suitable for its intended use

·     
clinical
validity :- to check if the patient truly has the documented condition

·     
clinical
utility:- usefulness of the test in improving the patients outcome

The diagnostic tests
used in personalized medicine are mostly IVD’s

which checks if the
individual has altered biomarkers. and the presence/absence of genetic
susceptibility biomarkers. IVD’S are marketed into IVD kits developed by a
conventional device manufacturer and sold to labs, hospitals and physicians
offices and LDTs are those that are designed, manufactured, and used by a
single laboratory. However the FDA has control over the regulation of the LDT’S
so that they give accurate measurement values even when made by different
manufacturers. The product interdependency plays a vital role in personalized
medicine making sure the therapeutic intervention and the therapeutic product  are beneficial to the user and not harm them.
In cases where a test is essential for the safe and effective use of a
corresponding therapeutic product, it is termed a “companion diagnostic.”

companion diagnostics
are useful in when new medicine or new diagnostic devices are made usually
these 2 are made by different organizations such things are termed as
co-development. Development of companion diagnostics
together with therapeutics should allow for more efficient studies with smaller
patient populations while also leading to more focused therapies that offer
better outcomes, less toxicity, and fewer treatment delays.

Clinical trials take place before a drug
is being marketed to the targeted population. These trails are in accordance
with the FDA’s “Enrichment Strategies for Clinical Trials” which is a draft
introduced in 2012 to choose the right people for the clinical trials so there
won’t be any bias. development.
co-developments are regulated by Shepard programs by the FDA so that they stay
in constant communication with the sponsors for tailoring to the needs of the
people.

Through such
strategies Vemurafenib is a drug for treating late
stage melanoma which was approved by FDA in near record time (3.6 months)
through this process as a result the outcome for the prognosis for this disease
was better.

After the medicine is made it is labeled
scientifically so that the prescribing physician can give the dosage depending
on the factors such as age region and race. And drug is constantly updated
whenever any new changes are made listing out the side effects and the
contraindications of the drugs. In order to prevent any mishap for the
consumers.

Whenever the drug is updated after a new
study the labeling is also updated so that it can carter to the needs of the
people.

Pharmacogenomics information can appear in
different sections of the labeling Therapeutic Indications, Warnings and
Precautions.

A guidance table is made which contains
information of the time of approval of the drug, the disease which it treats
and the biomarker which Is related to the disease is also given so that the
physician can confirm if the concerned person has the disease before initiating
the treatment.

 A
post marketing surveillance is done after the medicine is being released into
the market this collects the long-term data of the effects of the medication on
different population living in different sub continents and all the data is
being collected and sent to the FDA. This data includes the electronic data of
the patient and what they were afflicted with before and after treatment. This
is one in case if the marketed drug causes some adverse effects in the long
run. Even though clinical trials and studies are conducted before approving the
medication by the FDA. These trails have been only undergone in a small group
of people in each phase when compared the huge population to whom this
medication is marketed to.

So, the FDA has developed a sentinel
system via FDA’s Mini-Sentinel pilot program, a large-scale working model of
the eventual full-scale System.

The Mini-Sentinel System provides secure
access to the electronic health care information of more than 125 million
patients, provided by 17 data partners nationwide. 

The objective of FDA for medicinal Equipment
post- advertise observation is
the production of a national system that serves four primary functions:

1) Communicates timely, accurate,
systematic, and prioritized assessments of the benefits and risks of medical
devices throughout their marketed life using high quality, standardized,
structured, electronic health-related data

2) Identifies potential safety signals in
near real-time from a variety of privacy protected data sources

3) Reduces the burdens and costs of
medical device post-market surveillance

4) Facilitates the clearance and approval
of new devices, or new uses of existing devices.

CDRH
is pursuing four key proposed actions to help fulfill the vision for a National
System:

1) Establish a unique device identifier
(UDI) system and promote its incorporation into electronic health information.

2) Promote the development of national and
international device registries for selected products.

3) Modernize adverse event reporting and
analysis.

4) Create and utilize new techniques for
prove age, union, and evaluation.

The patient follow-up registry will help
the in keeping track of events that take place over the long-time due to action
of medication these things will be noted down and appropriate alterations will
be made to the personalized drug.