The Food and Drug Administration of the United States ( FDA ) is one of the oldest and most important regulatory agencies in the world regarding medicines and their proper functioning to protect people's health. However, the changes that are experienced daily have also forced it to be constantly updated.
The FDA (Food and Drug Administration) has published a guide for the pharmaceutical industry with the aim of providing more clarity on the development of generic drugs . Specifically, it collects information on how companies should proceed to request the designation of competitive generic therapies (CGT)
In addition to taking appropriate measures to improve the competence of generics, the FDA is working to make the development of these drugs more efficient . Along these lines, the organization studies reducing approval times and providing greater transparency.
The following is a brief description of the steps necessary to achieve drug labeling FDA approval:
• Making a medicine: A company do generic drug product development and requests FDA approval to sell it in the United States.
• Animal testing: Before assessing the medication in people, the company should test the new medication in animals to see if there is a likelihood of causing serious harm (for example, toxicity).
• IND request (for research of a new drug) The company submits a request for research of a new drug (IND) to the FDA based on the initial results of animal tests. These results should include the composition of the drug and the manufacturing and the proposed plan for the evaluation of the product in people.
• Clinical trials: After the FDA evaluates and approves the request for research of a new drug (IND), clinical trials with people can be initiated . There are 4 phases for clinical trials, beginning with small-scale trials and followed by large-scale trials. After clinical trials, the researchers present the study reports to the FDA.
• Request for a new drug (NDA) Once the drug manufacturer submits evidence that it is safe and effective, the company can submit the request for a new drug (NDA). The FDA reviews the request and makes the decision to approve or not approve the medication.
• Medication labeling : The FDA reviews the labeling or labeling to make sure that it communicates correct and appropriate information to health professionals and their consumers.
• Facilities inspection : The FDA inspects the facilities where the medication will be manufactured.
• Medication approval: The FDA approves the NDA application (request for a new drug) and sends a response letter.
• Post-marketing monitoring: Once the FDA approves the medication, it requires companies to undergo FDA safety inspections regularly.
FDA proposes new guide for drug labeling
Among the main changes proposed, the guide emphasizes that the indications on the label “must accurately reflect scientific evidence, as well as being written concisely to include the necessary information that clearly conveys the uses in which the drug has proven safe and effective. ”
Similarly, the terminology used must be "clinically relevant and scientifically valid and understandable to health professionals." In addition, the labeling must clearly specify the age groups indicated for the medication.
FDA approval
When pharmaceutical companies develop a new medication, they conduct a series of studies to ensure that the medication is safe and effective before it can be sold and prescribed. Medications may be approved for:
• A specific disease or group of diseases
• People of a specific age
• A specific problem (for example: pain)
• A specific condition, such as obesity or pregnancy
Once the medication is approved by the FDA for a particular use, doctors can decide whether it is appropriate to use it in other patients. This is called prescribing medication for use “outside of what is indicated on the label” (“off-label” in English). It is called "outside the label" because the label of a medication indicates for which use it has been approved by the FDA.
Prescribing outside the label is quite common. There are many medications with uses outside the indicated that the doctors agree are effective and present no risks. Once a drug is approved for single use , the company does not usually bother to be approved again . The process costs a lot of money.
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