The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions. While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD. The number of receipts in July was 40, […]
Imagine an industry where approximately 40% of firms inspected receive Warning Letters and nearly 100% receive substantial FDA Form 483 observations. Publically available information indicates that the FDA has issued 19 Warning Letters to compounding Pharmacies just in 2015 and 41 and counting to date in the last two and a half years. There have […]
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a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here) which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods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 […]
For those of you who have requested specific brand names from the FDA for your products and have had numerous names denied for reasons you cannot wrap you head around, take heart that FDA can make a mistake too. FDA reported today that there were at least 50 dispensing errors between two products that actually underwent the rigorous FDA name review process.
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Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.”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 […]
