Generics

25
Oct

FDA Plans to “NIPP” it in the BUD

The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”.  With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major […]

Read More
24
Oct

Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?

This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara If there’s something strange in your neighborhood; Who you gonna call?  If there’s something weird, and it don’t look good; Who you gonna call?  Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on […]

Read More
17
Oct

Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets.  The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in […]

Read More
10
Oct

What Was Old is New Again

Thirty-six years ago as a young Pharmacy post-graduate, I was introduced to the “Continuous Process”. Merck commissioned the plant housing this process in the late 1970’s in the Shenandoah Valley of Virginia. Building on the company’s experience with continuous chemical processing, the plant manufactured a blockbuster (at the time) anti-hypertensive “Aldomet”, Methyldopa Tablets, USP. At […]

Read More
05
Oct
Every Word Counts! Or Does it Image

289 Pages of Pure Hatch-Waxman Joy

The FDA pre-published a Final Rule (here) today implementing Title XI of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003.  FDA has been regulating directly from the statute since 2003 and now (based on various court decisions and FDA’s experience) has finalized implementing regulations for portions of the Act some 13 years […]

Read More
1 52 53 54 90