FDA approves Pfizer’s nasal spray for migraine
The U.S. Food and Drug Administration on Friday approved Pfizer Inc’s nasal spray for migraine, giving patients access to a potentially fast-acting option to treat their headaches.
The drug Zavzpret, also known as zavegepant, was approved for the treatment of acute migraine with or without aura ...
How prepare for FDA inspection?
If you’re like most small businesses, you probably don’t give the Food and Drug Administration (FDA) much thought. But if you’re a business that makes or sells food, drugs, medical devices, or any other type of FDA-regulated product, it’s a good idea to familiarize yourself with ...
When prepared for FDA inspection?
FDA inspections are an important part of ensuring the safety and efficacy of products that come into contact with the public. The FDA tests products to ensure they are safe, effective and meet all label requirements.
When you receive notification from the FDA that your product has been recalled, the ...
FDA expectations for an acceptable deviation investigation
A. Deviations happen. FDA recognizes this and requires deviations to be investigated and documented. Thorough and timely deviation investigations are critically important. Typically, deviation investigations should be led by the Quality Unit and conducted in collaboration with the operational department ...
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, ...
Importance of FDA Compliance
Before moving on to best practices for compliance, it’s important to understand the importance of compliance. Compliance with regulations is a guarantee of quality and safety of pharmaceutical products. It shows that the products are safe and effective. While non-compliance can lead to serious ...
Tips for a Successful FDA Inspection in Pharmaceuticals
It is the responsibility of the FDA to ensure that pharmaceutical products are safe and effective. To ensure this, the FDA inspects the pharmaceutical manufacturing facilities. This inspection of pharmaceutical manufacturing facilities is known as regulatory inspection. There are some important things ...
Tips for FDA Inspections
Conducting an FDA audit these days is becoming difficult as many warning letters are being issued to various pharmaceutical companies. Below are some tips for handling an FDA inspection properly.
1. Be confident, polite and courteous during the audit. If employees seem confident during the audit, a good ...
