Opioids and Benzodiazepines to Get FDA’s Strongest Warning

The FDA announced in a safety warning today (here) that it was adding a Black Box Warning on all opioid and benzodiazepine products due to continued concern relative to potential fatal interactions and severe adverse events.  The warning notes that the “FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects,

202 Page FR Notice – Final Rule for Revised Drug Listing and Manufacturers Registration, Take Note!

Have some spare time on your hands?  Read the new Final Rule that FDA pre-published today (here) .  FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in conformance with section 510 of the Federal Food,

“Proper” Was Not Proper in Guidance

Today, FDA reissued the Guidance for Industry: Abbreviated New Drug Application Submissions-Refuse to Receive for Lack of Justification of Impurity Limits, but the word “Proper” was removed from its title.  The title of the previous version read Abbreviated New Drug Application Submissions- -Refuse to Receive for Lack of Proper Justification of Impurity Limits (emphasis added).

Fidaxomicin BE Recommendations Consistent with FDA’s Vancomycin BE Recommendations-Almost!


Fidaxomicin, like vancomycin, is indicated for treatment of Clostridium difficile-associated diarrhea.  Both drugs are poorly absorbed systemically and treat the condition locally in the gut and intestines. Vancomycin, however, appears to be more soluble that fidaxomicin over the range of physiologically-relevant dissolution media.  The innovator of fidaxomicin submitted a petition,

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim on a job well done!

So How Many ANDAs and 505(b)(2) NDAs Have Had Approval Delayed by Petitions in 2015?

For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications.  Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs,

Follow-up on PIC/S Data Integrity Guidance

We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a regulatory agency Guidance document.

So How Many Patents Are Listed in the Orange Book Each Year?

Sponsors are required to submit information in their NDA filings to include “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture,

PIC/S Draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”

 It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection by ensuring the data is “…complete,

July 2016 ANDA Approvals and Receipts Numbers Announced

The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here).  So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY).   OGD did say there would be good and bad months for approvals and the July number of 46 ANDA approvals is the second lowest this fiscal year (the lowest was 43 in January 2016).

Dietary Supplements Back in the News with FDA Issuance of New Draft Guidance

There has been a spate of blog posts on our site regarding dietary supplements and yet again today we are addressing a newly issued revised draft Guidance, entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (here).  FDA notes that, under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

Dietary Supplement Manufacturers, Are You Ready for FDA?

The dietary supplement industry has been burgeoning since the 1990’s when the number of products on the US market was approximately 4,000. In 2015, the journal Drug Testing and Analysis estimated the number of US manufacturers to be approximately 15,000, accounting for more than 90,000 products and a $40-billion-dollar industry.  The Lachman blog has extensively covered issues associated with dietary supplements that contain hidden drug ingredients,