Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here). The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products. The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants.
Thanks for reading our blog this year,
We write them with feeling and lots of cheer.
With GDUFA, QbD, and OPQ to understand,
Our team searched for news from throughout the regulated land.
The year 2105 went by so quick,
Picking the best blog topics was really the trick.
FDA approved the first genetically engineered fish which they have determined is safe for our food supply. The fish is engineered to grow faster, which will, of course, make it a more abundant food source. Who knew a fish could be approved through a new animal drug application (NADA)? Not me!
Many of you reading this blog may not remember the Star Trek “Replicator”. In the Trek far future, members of the crew, when hungry, would simply walk up to this device and key in what they wanted to eat. The Replicator would then build a suitable, tasty meal by mixing the right combinations of materials.
The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.” Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food,
Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here) which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”.
Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.” The document outlines the FDA’s thinking on the use of quality metrics data “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”
The buzz about abuse-deterrent opioids (no pun intended) in some camps seems to view these products as a panacea for the prescription drug abuse problem. In my view, that is far from the reality of the problem and clearly miles from the solution.
The FDA has posted a Drug Safety Podcast on its website (here) that describes an adverse drug event (ADE) associated with use of a drug indicated to treat attention deficit hyperactivity disorder (ADHD).
On March 26, 2015, we blogged about an April 20-21 FDA Public Hearing regarding examining the need for the drug enforcement policy surrounding homeopathic drugs. Since the conclusion of that hearing, just under 3500 comments have been received from FDA.
Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission of NIR analytical methods.
Dr. Kathleen (Cook) Uhl, OGD’s Director of the Office of Generic Drugs (OGD) will be going on an extended medical leave beginning on Monday, March 30, 2015.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.