November 2019 Approvals and Receipts Official Numbers

Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases.  We reported 49 full approval actions and 8 tentative approval actions on December 3rd.  With the release of the official November numbers (here), OGD issued 59 full approval actions and 10 tentative approval actions,for a total of 69 approval actions for the month or 4 more than last month (57 full and 8 tentative approval actions).

Hand with classic stopwatch

Will Blocking Act Block Savings?

In a blog post, Kurt Karst (Hyman, Phelps, and McNamara) addressed at least one very significant issue the proposed Blocking Act of 2019 could have (here).  Many believe that the change from the current legislative language may erode the value of 180-day exclusivity and, in the long run, could lead to higher drug prices.

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

Woodcock and Churchward Give Stimulating Presentations at Last Week’s ISPE Global Regulatory Summit

The International Society of Pharmaceutical Engineering (ISPE) held their premier Global Pharmaceutical Regulatory Summit conference this past Thursday and Friday (December 5 – 6, 2019) in Bethesda, MD.  The theme of this year’s conference was “Igniting Innovation in Development & Quality During Lifecycle Management”.  The conference opened with excellent keynote presentation from Janet Woodcock (Director of FDA’s Center for Drug Evaluation and Research) and David Churchward (Deputy Unit Manager,

The Case of NDMA – Is Metformin Next?

N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine  (a heartburn medication) has caused nationwide recalls of the products.  Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences Authority (HSA) recently announced a recall of several lots of the product in Singapore.

Baseball Player Hitting Ball During Baseball Game In Outdoor Stadium

Training Fundamentals: Important to Baseball and the Analytical Laboratory

Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It is interesting that the ICH Q10 Pharmaceutical Quality System guidance recommends pharmaceutical management take the same approach towards quality objectives. 

How Much Does the Clear Out of the Backlog Really Impact Approvals?

Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks.  Granted, the backlog of old applications did contribute to the number of approvals but,

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency has struggled with evaluation of novel excipients in INDs,

John Darby, new Senior Director in the Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that John Darby has accepted the position of Senior Director at Lachman Consultants, effective December 2, 2019.

Mr. Darby is a goal directed, results-focused executive professional with a strong, global background in quality assurance, compliance, audits, training, and remediation. His 18 years of experience and keen insight contribute to his ability to identify issues and form innovative solutions and strategies for continued success.