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 been numerous recalls due to lack of sterility assurance,
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a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here) which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods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 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 to the lower number of ANDAs that have been submitted so far in 2015 (377 through June 2015 with a straight line projection at that rate of 502 to be submitted in FY 2015).
Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.”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.”
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 assisted in and cooperated with authorities in the investigation.
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.
For years, FDA has been indicating that it was planning to take enforcement action against certain marketed unapproved prescription and OTC ear drops, but, yesterday, the final shoe dropped on the marketing of such products, as FDA published its intent to take enforcement action against these products in a Federal Register notice (here).
FDA first released its guidance on Controlled Correspondence Related to Generic Drug Development in August 2014. We previously blogged about this guidance (here). In today’s Federal Register notices, FDA provided its response to comments received on the Guidance document.
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.
In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015.
The FDA is looking for a few (or a lot) more good employees and is holding another virtual hiring event. Could FDA be looking to obligate a portion of the $277 million excess of GDUFA funds that have not yet been spent from the fees collected in the first 2.5 years of the program?
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.
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
In a Federal Register notice today (here), FDA announced its finding that Ondansetron Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.
In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.