Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i]. This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations. In 2016, […]
OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative […]
In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products. The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies […]
A combination product, which is a combination of a drug or biologic with a device delivery constituent part, are typically designed, developed, and maintained under a robust manufacturing process. This article is targeted for companies that have existing combination products on the market or are prepping their quality management systems to be compliant with the […]
Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]
A question that may be raised by industry professionals is, “How does the upcoming ICH Q14 guideline impact the methods that I currently use?” The FDA’s July 2015 Guidance for Industry: “Analytical Procedures and Method Validation for Drugs and Biologics” references analytical method development, the use of statistical tools during method validation, and life cycle […]
In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020. The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020. The medical device fees are provided in the […]
In announcing the July 24th approval of Baqsimi (glucagon powder for nasal administration) (here) FDA notes that it is the first form of glucagon that can be administered without injection. The product is to be used by a caregiver or we assume someone on the street if the patient is unconscious. The product is a […]
FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was […]
We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events. In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached. We can stream tv shows, live […]
