Who would have guessed that 21 CFR 314.94(a)(9)(iv) no longer applies to ophthalmics? You wouldn’t generally have expected it to just be cancelled – normally FDA must go through notice and comment, but apparently the FDA can make a regulation disappear by decree. 21 CFR 314(a)(9)(iv) states: (iv)Inactive ingredient changes permitted in drug products intended [...]
Archive for the 'Formulation Issues' Category
Ophthalmics: 21 CFR 314 94(a)(9)(iv) no longer applies
Published June 2nd, 2011 in 505(b)(2) Process, ANDA's and Formulation Issues. 0 CommentsInjectables: 505j or 505(b)(2)?
Published February 1st, 2011 in 505(b)(2) Issues, ANDA's and Formulation Issues. 0 CommentsGeneric injectable drug products are treated differently than other routes of administration when it comes to permitted differences from the RLD. For most dosage forms, the sponsor is allowed to change excipients as long as the test product is bioequivalent to the RLD. No so for injectables, the excipients must be the same. If the [...]
Pharmacokinetic (PK) Modeling & Steady-State Simulations: Strategic Use in a 505(b)(2) Drug Development Program
Published December 13th, 2010 in 505(b)(2) Process, Formulation Issues and How to:. 0 CommentsSponsors and their investors continue to seek cost efficient ways to meet their financial milestones. Modeling can be used as a cost effective way to estimate the effect of changing an oral product from immediate release to extended release. Modeling avoids the cost of making multiple formulations and performing several multi-arm pharmacokinetic studies. The following [...]
Nuedexta® – Smart Pharmacology to Treat a Unique Disorder
Published December 11th, 2010 in 505(b)(2) Process and Formulation Issues. 0 CommentsThe FDA has approved NuedextaÃ’ (Avanir Pharmaceuticals Inc.), a drug that curbs involuntary and uncontrolled crying and laughing episodes (known as pseudobulbar affect (PBA)) that are experienced by patients with some neurological disorders. Nuedexta is the first drug to be approved to treat patients with these symptoms. Nuedexta is a combination product containing dextromethorphan hydrobromide [...]
Generic or 505(b)(2)?
Published November 29th, 2009 in 505(b)(2) Issues and Formulation Issues. 0 CommentsIs an opioid product that has abuse resistant characteristics but otherwise the same as the RLD a generic or 505(b)(2)? Readers will know that Camargo has been involved in many opioid-related projects. We have been to FDA’s DAARP 13 times this past year alone. What is the objective of most of these meetings? For the [...]
505(b)(2) for formulation changes
Published October 20th, 2009 in 505(b)(2) Issues and Formulation Issues. 0 CommentsA couple of weeks ago I was invited to present at the 2009 Nebraska Research and Innovation Conference. The theme of my talk was “The Case for Improving Existing Drugs”. There are several factors driving people to the 505(b)(2) development pathway, a couple of which are: Generic cliff. By about 2017 there will be very [...]
Risk Evaluation Mitigation Strategy (REMS) for long-acting opioids
Published June 4th, 2009 in 505(b)(2) Process, Formulation Issues and News Commentary. 0 CommentsCamargo is working with several clients in developing better treatments for pain. Unfortunately, the active substances that supress pain also can be abused. The FDA and DEA are trying to find ways to allow access to these medicines while imimizing the inherent risks of drug abuse. In order to properly advise clients, Camargo attends various [...]
One vs. Two batches for single-dose and multiple dose studies
Published March 19th, 2009 in CMC Issues and Formulation Issues. 0 CommentsToday’s posting stems from a client question. The client’s product candidate is an oral product that requires both single- and multiple dose pharmacokinetic studies. Question: Do companies ever use one pivotal batch for single-dose (SD) study and another batch for the multi-dose (MD) study? What are the pros and cons of doing this? See the [...]
CMC Bridging Studies
Published March 16th, 2009 in 505(b)(2) Process, CMC Issues and Formulation Issues. 0 CommentsWe have discussed bridging studies in this blog before in the context of the phase 1 bridging study to link the safety and efficacy of the RLD to the proposed drig product. So, what is meant by a bridging study for CMC* purposes?During the 505(b)(2) drug development process we often change the formulation, components or API. [...]
Labeling for Abuse-Deterrent Drugs
Published June 10th, 2010 in Formulation Issues and News Commentary. 0 CommentsThis past Tuesday (6/8/2010), we participated in a DIA-sponsored webinar entitled Understanding the Development and Label Allowances for 505(b)(2) Abuse-Deterrent Products. Joining me, Ruth Stevens our CSO and Cindy Phurrough, our Clinical Operations head, was Dr. Lynn Webster, Chief Medical Officer of Lifetree Clinical Research and Pain Clinic. Ruth reviewed the regulatory background, the types [...]