Not that it is a big surprise to current users (at least we hope not), but the FDA announced on October 23, 2013 that they were completing the phase-out of all medical inhalation products containing chlorofluorocarbons (CFCs) by December 31, 2013.
In a recent enforcement action against a dietary supplement manufacturer James G. Cole Inc. (here), the FDA is seeking a Permanent Injunction based on repeated violations of cGMPs and distribution of unapproved drugs. This type of “health fraud” dates back to the days of the traveling medicine men in their covered wagons selling dangerous concoctions of different herbs and drugs and making all kinds of wild health claims for products like Doctor Feel Good Elixir.
On October 11, 2013, the FDA made history by approving Nasacort Allergy 24H, an over-the-counter (OTC) version of the Rx Nasacort AQ (triamcinolone acetonide), a nasally inhaled glucocorticoid for allergy relief.
Hardly! But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on the final revised ruling.
If you are a developer of apps for a mobile platform, are your apps medical devices, and if so, what requirements do you need to meet? The answer took FDA 43 pages to lay out in their new Guidance for Mobile Medical Applications, which was issued on September 25, 2013. And the answer is, well, it depends!
Today, the FDA announced a change in labeling requirements for all Fentanyl Transdermal Systems in an effort to prevent inadvertent overdose. FDA is also warning patients and caregivers to dispose of patches properly, and warning that patches that do not adhere properly to the patient might fall off and accidentally adhere to another person, such as a child or a caregiver, or even a pet, and, based on the amount of drug left in the patch (should this occur), could cause death!
GPhA filed a Citizens Petition on September 19, asking FDA to implement its INN naming policy equally to all biologics, and, in the Petition, articulated all the arguments as to why this is a necessity for future biosimilars being approved by FDA.
Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks. In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were singing the same tune on the issue of amendments (and supplements) to abbreviated new drug applications (ANDAs) submitted prior to the June 20,
Ever since the meningitis outbreak associated with the products from the New England Compounding Center, the FDA and the States have been taking a closer look at this segment of the industry. So far, in 2013 alone, the FDA has issued 51 Safety Alerts for Human Medical Products, of which 17 (33%) related to sterile pharmacy compounded products and/or laboratories that tested those products for sterility and/or potency. In addition, FDA has taken 54 separate actions against compounding pharmacies in 2013 alone, with only 24 actions taken in the previous 5 years.
On August 20, 2013, FDA and the EMA (European Medicines Agency) published a document entitled, “EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: Lessons learnt and Q&A resulting from the first parallel assessment.” The Q&A document provides information regarding agreements that were made between the agencies as a result of the first FDA-EMA parallel assessment that was conducted in a three year pilot program that began in March 2011.
Yesterday, the FDA released an update to its 2007 Questions and Answers document on Medical Foods. Interestingly, it is the new information in this document that has us scratching our heads about the implications of this revised draft document.
FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013. Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues. That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling. It could also require a change to a REMS program or patient information sheet.
, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet and a Question and Answers document. Today the contents of those documents have been incorporated into a Draft Guidance
At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs. The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs. Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.