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a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here) which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods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”. The new Guidance covers the required information relating to […]
The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises. For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due […]
Late Tuesday evening, the FDA placed a “Dear Applicant Letter” on Regulations.gov relative to a request for comments from interested and affected parties on two very interesting issues relative to 180-day exclusivity. The drug product in question is Cyclosporine Ophthalmic Emulsion. As part of its consideration, FDA is considering whether the fact that FDA did not issue an Acknowledgement Letter for this drug product until after the patent expired impacts this analysis. FDA also seeks comment on whether there are any other factors that are material to this question.
Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.”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 innovator for Lubiprostone (trade name Amitza) petitioned the FDA to change the requirements for demonstrating bioequivalence of the product to require additional BE studies with clinical endpoints for various other approved indications. The FDA explained in its denial letter that it has been reviewing the approval requirements for all locally acting drug products in the gastrointestinal (GI) tract and had decided to revise its BE recommendations for all. However, its revised recommendations actually made the path to approval for a duplicate version of the drug potentially easier for generic entrants.
In a Federal Register Notice today, the FDA announced the termination of permanent debarment of David Brancato. David was one of the original FDA staff members implicated in the Generic Drug scandal. He was originally debarred on January 6, 1994. Special termination of debarment can occur when there is a determination that an individual substantially […]
Yesterday, a reporter asked me how long has there been a backlog at the Office of Generic Drugs (OGD). I told the reporter that the nature of the ANDA review and approval process will guarantee that there is always a backlog. That is because firms submit applications on an ongoing basis, and it takes the […]
he newly posted and updated Paragraph IV list, which provides the date that the first ANDA with a patent challenge was received by the FDA, has four very interesting listings, all of which make it clear that generic firms are not letting the moss grow under their feet.
There are numerous FDA-approved combination cough syrups on the market. In addition, Codeine with Guaifenesin is an OTC monograph product that can be sold without prescription in many states. The use of these products in pediatric patients (under 18 years of age) can cause breathing and respiratory problems.
June 2015 saw the largest number of approvals in a single month since the start of GDUFA, at 57 full approvals and 10 tentative approvals, while receipts were a meager 37. This reverses a long trend of receipts outpacing approvals and represents a month where the backlog actually has an absolute decrease of at least 30 applications.
