Data integrity (DI) has been a problem for as long as I remember, and my memory goes way back. The first real exposure I had to DI issues dates to the early days of Hatch-Waxman, passage of which had led to the generic drug scandal of the late 1980s. I could write a book about all […]
As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual. Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]
At the Generic Drug Forum virtual SBIA event that is still ongoing, Andrew J. Fine, PharmD, BCPS, Senior Advisor, Division of Clinical Review, Office of Safety & Clinical Evaluation, Office of Generic Drugs, provided a look at the type of information that needs to accompany a complex product (particularly a drug device combination) to establish […]
In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting. As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]
GET EXPERT ADVICE AT MEDTECH FORUM 2022 After four years in the works, the U.S. Food and Drug Administration (FDA) has finally published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on 2/23/2022. This proposed rule not only impacts U.S. manufacturers but all manufacturers with product in […]
If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen! […]
Used for years as an “unapproved” drug for lightening of skin color, the FDA issued warning letters to twelve firms selling the drug, telling them that hydroquinone is not generally recognized as safe and effective. On August 29, 2006, the FDA issued a Notice of Proposed Rulemaking that would establish that over-the-counter (OTC) skin-bleaching drug […]
According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of […]
April showers bring May flowers, as the saying goes. Well, April thus far has not showered down approvals as, halfway through the month, the OGD stands at twenty‑one full‑approval actions and three tentative‑approval actions. If the trend continues through the end of the month, we could be heading for a month with less than fifty […]
During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.” Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.” She discussed product loss resulting from five-micron […]
