This page discusses Drug Development in the US and the role of the FDA.
What is the FDA?
The FDA (Food and Drug Administration) is a United States agency that’s part of the United States Department of Health and Human Services.
They are the ones who supervise, protect, and promote the regulation of vaccines, medical devices, food safety, dietary supplements, cosmetics and much more.
They are the ones who put the stamp of approval on all these products. There’s a lot of research, testing and work that goes into allowing any drug to be sold to the masses on the market.
The FDA’s Center for Drug Evaluation and Research (CDER) is the FDA’s largest of their five centers. They are responsible for non-prescription (or over-the-counter drugs) and prescription drugs.
Companies who want their products sold to the public need to submit an NDA (new drug application), proof that they’ve done laboratory animal testing and any human testing. They need to submit all their data and the FDA has 60 days to decide if they will review it. If the entity that submitted the application is missing information, then the FDA has the right to reject the review.
The CDER has no more than 10 months to start reviewing the drug after the application is accepted. Chemists, pharmacologists and physicians will review the application and see if it will go onto the next step.
They will check everything-from side effects, to conditions under which the drug has to be manufactured, to the design of clinical trials. Honestly, most drugs don’t ever even make it to the FDA.
The ones that do are brought before the IRB (Institutional Review Board), which is made up of scientists and non-scientists who look over the clinical research.
The drug must be considered “safe”, meaning the side effects aren’t that severe compared to the benefits of taking the drug.
For example, a birth control medication might cause slight hypertension and minor weight gain.
These are some reported side effects of Yaz and similar contraceptives, but the drugs' benefits of stopping ovulation and significantly reducing a woman's menstrual pain were taken into account before Yaz was approved by the FDA and reviewed by the IRB.
The side effects and benefits are crucial clinical data which are studied and weighted by members of the IRB.
Even though they have given the OK, the FDA can still seek advice from advisory committees who give outside advice on the drug.
This advice may include what the drug market is looking like or any concerns that should be discussed before the developed drug is introduced to the general marketplace.
What about generic drugs? Are they processed in the same way?
Well, generic drugs (which are similar to a brand name drug in dosage, quality, strength and use) have to be accepted through an ANDA (abbreviated new drug application).
This is the way that they are reviewed, since generic drugs don’t have to pass through the preclinical (animal) and clinical (human) studies again to determine if they are safe or effective.
What these drugs manufacturers need to prove is bioequivalency. That means the drug has to provide the same results as its original. Testing for bioequivalency is done by using of 24 to 36 healthy human volunteers to see how fast the body absorbs the drug and that the drug can deliver the same amount of active ingredients as the brand drug does. So it should deliver at the same rate and just as much as the original.
This process has been going on since the Drug Price Competition and Patent Term Restoration Act of 1984, or the Waxman-Hatch Act. This allows the FDA to process generic drugs faster without having to do expensive clinical trials that already took place with the brand name drug.
Still have questions about Drug Development? Head on over to the Have A Question? page and ask your question(s) there.
Grab this Collection of over 20 E-Books!
So, you've found this page and you're wondering "What is the Premium PharmTech Package and Why Am I Going to Invest in it "STAT"?"
Clearly you need to know how this Premium Collection of e-Books and e-Reports has the potential to impact your life, improve your career, your job satisfaction, your workplace relationships, and maybe even your income. Can an collection of digital downloads do that? Read on...
This Fantastic Collection of over 20 e-Books and e-Reports is Hand-picked just for you. You see, I'm pretty sure I know something about you...
What would you pay to learn...
Imagine, just for a moment, what work would look like for you, after you invest in yourself and get this VALUABLE, JAM-PACKED e-Book Package... and apply what you've learned...
These examples are just the "tip of the iceberg" on all the stellar content you will soon be reading and applying.
While you're sitting there reading this page, you begin to understand why you can't afford to waste any more time getting less than everything you deserve in your pharmacy tech career.
As you think about what you need in your career, you begin to realize that you have only one choice to make, and that is to invest in yourself and grab this Premium PharmTech Package.
Scroll down to see all of the resources (PDF digital downloads) included in this UNBELIEVABLE Deal...
Premium PharmTech Package
Powerful and Invaluable Knowledge from an
Experienced Pharmacy Insider is YOURS
Take Months off your Learning Curve!
Let this Premium E-Book Package
help you NOT have to reinvent the Wheel!
Invest in yourself and your career!
You are clicking on the "Buy It Now" button ;)
and Checking Out Now
(before this SPECIAL OFFER goes AWAY for Good)
Didn't find what you were looking for? Use the box below to search this entire site.
Dec 06, 17 11:16 PM
How do you set this up to solve to find the days supply?
Nov 27, 17 11:39 PM
Neurontin 300 mg tablets #15 1 tab po qod What is the days supply?
Nov 27, 17 11:25 PM
Take One Tablet by Mouth Every 4 Hours As Needed for Pain Not To Exceed 6 Per Day
Nov 18, 17 07:44 PM
Pharmacy Technician Cover Letters - The basic format to use when writing your Cover Letter, as well as what to write to make sure your resume gets moved into the "interview" pile.
Nov 18, 17 06:16 PM
If you have 20 pills and you take 1.5 a days what's the days supply
Nov 18, 17 06:05 PM
Your pharmacy stocks stavudine in bottles of 30 capsules. How many capsules would you need to dispense for a 90 day supply?
Nov 18, 17 02:17 AM
Duties and Responsibilities of the Hospital Pharmacy Technician.
Nov 18, 17 01:20 AM
This page discusses how Pharmacy Technicians use the Metric System of Measurement.
Nov 04, 17 10:37 PM
What is the days supply on advair 250/50 #1 - 1 puff q12h?
Oct 29, 17 10:40 PM
Pharmacy Root Cause Analysis (RCA) - What is an RCA? How can it help PharmTechs and Save Lives?
Oct 29, 17 10:12 PM
Controlled Substance Pharmacy Technician - Responsibilities, Qualifications, A Day in the Life, and Work Advantages
Oct 29, 17 09:54 PM
This page explains IV Infusion Calculations you may use in your job as a Pharmacy Technician.
Oct 29, 17 09:41 PM
How many days should 35 Norco last me if I was given #35 at 1 every 4-6 hours?
Oct 27, 17 08:01 PM
This page discusses ways of Improving Pharmacy Safety Culture - Focusing on Work Environment, Processes and Procedures, not Personnel
Oct 15, 17 04:54 PM
In D10W, how much dextrose is in a 250mL bag?