The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted […]
Back in May 2016, I wrote a blog post (here) about a budgeting proposal put forth by Senator Joe Manchin of West Virginia that would have financed opioid treatment programs by a tax on the opioids themselves. This would eventually have placed higher purchase costs on the patients that needed the drugs. Well, now, there […]
On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”. The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help […]
The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, […]
On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations. During the presentation, I was asked by […]
In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the […]
With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017. From data gathered from the daily approval report, I find at […]
FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers The […]
Appearing in today’s pre-publication of the Federal Register (here), the FDA announced the issuance of an Emergency Use Authorization (EUA) for an atropine autoinjector that has not been FDA approved to date. An EUA is issued by the FDA once a series of requests have been made and cleared for a product for a potential […]
Revision 3 of Manual of Policies and Procedures (MaPP) 5240.3 was published today and provides an update to include priority review for ANDAs for which there are fewer than three generic competitors. The MaPP also provides boundaries around when an ANDA will be eligible for priority review by providing a more specific set of conditions, […]
