Internet Drug News
User-friendly guide to the drug approval process and a directory of the best parts of the FDA 's enormous website; information on drug recalls.
FDA Information [ FDA Site Dissected At Bottom of this page]
The FDA is the Food and Drug Administration. The FDA is the official government agency that is responsible for ensuring that our drug supply is safe and effective. You should think of the FDA as an benevolent entity or person rather than a bureaucratic government agency. When speaking about the FDA, the word " the" is usually omitted by pharmaceutical industry experts because they consider "FDA" to be a proper noun like someone's name.
When a pharmaceutical company invents a new drug, that company is required to submit an NDA (New Drug Application) to FDA. FDA reviews the application very thoroughly, looking for objective proof that the proposed drug is safe and effective.
FDA will not approve an NDA until it is satisfied the new drug is SAFE and EFFECTIVE. (Those 2 words, " safe and effective" are something of a slogan or mantra at the FDA).
Those are the basic requirements of a potential new drug; It doesn't matter who invents it. If you want to market a drug in the USA, you need to prove that the drug is safe and effective.
If the FDA officials feel that a new drug is safe and effective, they will deem the new product "approvable".
At this point, most of the major hurdles for the new product have been overcome. At this point, labeling issues will be ironed out and loose ends need to be taken care of.
But there can be further obstacles. FDA can determine a drug to be safe and effective but they may insist that more clinical trials be conducted.
FDA may want more data on the drug's effects on heart rhythm when it is mixed with another drug.
Or maybe some of the test subjects developed a side effect. FDA may want more data on this so called "approvable" product before final approval is granted.
When a drug company gets an approvable status for a potential product, it is cause for celebration, although sometimes there is a considerable delay between approvable status and final approval because FDA and the company involved can not agree on final labeling.
Until final labeling is resolved, the product is put on hold. If you are a pharmaceutical whose drug's approval status is up in the air, you want to make sure that you behave yourself.
Pharmaceutical executives are concerned that final approval of a product may be delayed if the company is perceived as being as having a beef with the FDA.
The next step in the process is that the approvable drug gets an official Approval letter.
Once the drug company gets this approval letter ( not to be confused with an approvable letter) the drug company is officially permitted to market the drug.
If the new drug is truly innovative, and has life saving potential, FDA will deem it "Fast Track" and the approval process can take as little as 6 months. If the new drug is not innovative (like a 100th angiotensin II blocker, or some other me-too drug) the approval process can drag on for years.
How are drugs approved?
What are the key steps In Drug Approval process
Synthesis & Purification … FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects … click here for more
Animal Testing (short tem) … generally, two or more species (one rodent, one non-rodent) are tested because a drug may affect one species differently from another. Animal testing is used to measure … click here for more
Animal Testing (long term) … Long-term testing in animals ranges in duration from a few weeks to several years. Some animal testing continues after human tests begin … click here for more
Institutional Review Boards … used to ensure the rights and welfare of people participating in clinical ... make sure that participants are fully informed and have given their written consent … click here for more
Phase 1 Clinical Studies … phase 1 includes the initial introduction of an investigational new drug into humans … During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies…. Click here for more
Phase 2 Clinical Studies … helps determine the common short-term side effects and risks associated with the drug…. click here for more
Phase 3 clinical studies … intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug… click here for more
See Also> Drug Approval Process; from FDA; detailed explanation of how a drug proceeds from the inventor's brain to a pill at the drugstore; explains difference between Phase I, Phase II and Phase III.
See Also> Interactive Chart Explaining Drug Approval Process from FDA; Steps from Test Tube to New Drug Application Review in visual format; this is what Pharm D. candidates use to study about FDA's approval process.
See Also> NDA review process from FDA; interactive chart; very informative.
FDA is the government's "watch dog" over the American Pharmaceutical industry. FDA experts review drug advertising and promotional tactics for veracity and fairness.
If FDA feels that a company is marketing a product in a way that conflicts with its official, approved, labeling (sometimes called the Package Insert", they issue a warning letter to the company involved.
Getting a warning letter from the FDA is no laughing matter. Approximately two weeks after the warning letter is sent to the company, a copy of the warning letter is posted to the FDA website. [ See: Warning Letters; FDA web site].
Companies and their product managers take the matter very seriously and address the subject of the warning letter rapidly. When popular drugs get a warning letter, it can generate lots of (unwanted) media coverage.
In most cases, the recipient of the warning letter has corrected the problem cited in the warning letter before the letter is posted to the FDA website.
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Class I recall - situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall - situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall- situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The FDA Website is immense -- here are a few of my favorite pages from within the site. The FDA site is updated often -- your best bet is to go to the FDA homepage and search for what you need.
- Upcoming Meetings
official schedule of when a particular meeting will take place.
- Committee Info
Expert panel information; who they are what their affiliations are.
Written records of what was said during a particular expert committee meeting; this is the meetings that FDA has to determine if a new drug is approvable.
General Points Of Interest
FDA NEWS Wire (From Yahoo! - updated hourly)
FDA Aids Portal
Drugs@FDA: Immense database of products; Approved and tentatively approved prescription, over-the-counter, and discontinued drugs. You can get drug approval letters, labels, and review packages; the database can be searched by drug name or active ingredient. Very useful.
FDA Drug Approval Application Process
FDA Drug Shortages Page
FDA New and Generic Drug Approvals
FDA Site Index
FDA Talk Papers/ Press Releases
FDA Warning Letters ; PDF Format; Adobe Req.
FDA Product Recalls, Alerts and Warnings
Electronic Orange Book - searchable database of every drug approved by the FDA, both branded and generic. Also includes the patent and exclusivity status of the branded drugs."
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