FDA Acts to Remove the Rx Status of PEG 3350

It has been just about 11.5 years since FDA approved an OTC version of MiraLAX and the innovator withdrew the Rx-labeled NDA product from the market.  Why did it take this long?  Other than the fact that ANDAs approved prior to the approval of the OTC version were making significant profits, there were differences between how the ANDA applicants and the FDA viewed the change in labeling.

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4 New Paragraph IV Certifications Listed by FDA

Everyone associated with generic drug submission realizes that generic companies that want to market a copy of a drug product prior to the expiration of a patent must file a patent challenge to existing patents (a so-called Paragraph IV [“PIV”] challenge).  FDA updates its list of PIV submissions so other firms will know the date of a first filer. 

Median Actions on Inspections Reported By FDA

Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has recently issued and the full report can be found here.

The finish of a horse race

Coming around the Home Stretch, Heading for the Finish Line – It’s China by a Nose?

Despite being the co-leader and taking the number one or two spots in Warning Letters received with India for the last few years, China had made great strides in obtaining ANDA approvals.   According to an article by Jin Zhang M.D., Ph.D, on PharmaExec.com (here), Chinese firms received 38 ANDA approvals in 2017 (that is 5% of all approvals for the for FY 2017),

Clear Vision early fall in rocky mountains

Transparency for Decision-Making Process Coming to an Inspection Near You!

In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”  This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA).

The anticipated outcomes of the operating model will enable FDA to meet new challenges presented by the complex pharmaceutical industry intricacies. 

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AAM Testifies at Opioid Hearing

Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ).

The testimony addresses the following major points.

  • It is critical that we combat the misuse of prescription medication while maintaining legitimate,
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March Shows Increased Pace of ANDA Approvals

Since January 2018, the number of ANDA approvals has slowed dramatically.  In the first three months of FY 2018 (beginning in October 2017), ANDA approvals were averaging 83 a month. The monthly average for January and February was 28.5.

We know that the slowdown in approvals was due in large part to the change in documentation requirements for elemental impurities (EI) in all applications. 

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OGD First-Time ANDA Approvals for 2018 and What They May or Not Mean to Consumers

Even though the slowdown in ANDA approvals, attributable to the issues of elemental impurities, has dampened the first two month of 2018 (here),  the number of first-time generic ANDA approvals seems to be higher than would be expected.  FDA reported 10 first-time generics (note that there may be multiple reports for the same drug if multiple applicants obtain approval on the same day) through March 8,

Constance Richard-Math, new Director at Lachman Consultant Services, Inc.

We are pleased to announce that Constance Richard-Math has accepted the position of Director in the Compliance Practice at Lachman Consultants.

Constance Richard-Math joined Lachman Consultants after a 20-year career at the U.S. Food and Drug Administration where she rose to the position of Director, Investigations Branch at the Baltimore, Maryland District Office.

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OGD Dashboard Sheds Current Light on Workload

The Office of Generic Drugs (OGD) posted its updated Dashboard for ANDA workload activity on Friday.  The new posting is current through the first quarter of FY 2018 as of January 1, 2018.

Original ANDA Activity for Pre-GDUFA Year 3 Application Cohort

Total Original ANDA Workload Activity for All Unapproved Applications


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Flu the Coop!

Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu.  The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms.  In addition, they also warn patients to be wary of online pharmacy sites that may offer unapproved or fraudulent anti-viral products.

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US FDA Guidance – Good Clinical Practice: Integrated Addendum to ICH E6(R1)

The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here).  The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States.

The guidance clearly identifies the added revisions,