the FDA can ask for a recall. A recall may mean the company removes the product from the market or warns the public and corrects the problem. The FDA says most drug and device recalls are voluntary. When needed, the FDA can directly recall faulty medical devices. It can’t directly...
In this review, US Food and Drug Administration (FDA) Warning Letters (WLs) to pharmaceutical companies regarding post-marketing PV are discussed in an attempt to understand and learn from the failures identified, and, thus, continually improve the quality of PV globally.M. Gandelman...
Cease and desist letters are commonly used as notice in cases involving intellectual property infringements, harassment, defamation, or contract breaches. The goal of such notices is typically to give legal notice of the recipient’s actions and a warning of a possible lawsuit if the behavior co...
Class 1 devices (such as toothbrushes) typically do not require FDA approval, but manufacturers must self-certify, registering their company and device on the FDA website before they launch. This process of registration typically takes between 30 and 90 days. Class 2 These devices are deemed to...
gap between existing QMS standards and the new ISO 13485 regulationshould not be significant. For many, the majority of the labor and time will be spent ensuring new processes are well “documented” or “established,” a requirement that is fundamental to both the FDA and ISO 13485 ...
58 The FDA is also working with Health Canada to develop guidance on the assessment of QT prolongation during clinical trials.47 The final guidance is still pending. Through these initiatives, regulators are hoping to standardize preclinical and clinical cardiovascular testing of all drugs, an ...
An inspector calls When working in a regulated laboratory, inspections and audits are a fact of life. The third White Paper in this series (The Role of Analytical Instrument Qualification in Data Integrity with the 2017 Version of USP <1058>3) includes many examples of FDA warning letters, ...
Strange calls, emails, texts, or letters. Fraudsters may use information available on the Dark Web — such as your SSN or Medicare number — to trick you into thinking their correspondences are legitimate. Slow down, and look for the signs of a phishing scam. 📚 Related: Aura vs. LifeL...
Cease and desist letters can be quite effective. Businesses and individuals often choose to adhere to them to protect themselves against further legal action. At the same time, there are people who may choose to ignore cease and desist notices except for those issued by a court or a government...
In the late 1970s, the U.S.Food and Drug Administration(FDA) mandated that all prescription and over-the-counter (OTC) medical products be marked with an expiration date. Expiration dates for medicines are often marked EXP and may be printed on the label, stamped onto the packaging, or bo...