Competitive Generic Therapies – Be Careful, the Clock is Running and Timing is Everything

What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant.  We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first approved applicant for potassium chloride actually notified the FDA of its commercial marketing through the FDA’s electronic gateway) but the time window is really not relevant,

Of Drugs and Devices – The Saga Continues

The DIA Complex Drug-Device Combination Workshop was held at Sheraton Silver Spring on October 9‑10, 2018.  The second day’s discussion was dominated by issues related to transdermal systems and intrauterine devices.  The presenters on the second day were mostly from the FDA, with a few from academia and CROs.  The FDA presenters focused on quality expectations for devices,

Of Drugs and Devices

The DIA Complex Drug-Device Combination Workshop is being held at the Sheraton Silver Spring during October 9‑10, 2018.  The first day of the conference dealt with the regulatory aspects of the generic submissions for these kinds of products, and discussions on clinical aspects related to complex generics, with a focus on inhalation products.

The meeting was well-attended,

How Current is Your Stability Program?

A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing.  During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing.

Neither the current guidance ICH Q1A(R2) “Stability Testing of New Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.  

Controlled Correspondence Made Easier, But Watch Out

On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA.  The process is further explained here, including how to register for use of the portal.  This could help speed CCs to the Agency, but it is the problem with what happens to some once they reach the Agency that has raised some industry eyebrows,

The Importance of Trending During Laboratory Investigations

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness and effectivity of corrective action and determining whether there are any underlying cause/s for noted repeat incidents.

OGD Breaks FY Record on Approvals!

Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals.  We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but as it stands now,

Me KASA es Su KASA – Long Overdue but Very Welcome

On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA).  The FDA presented to the Advisory Committee two primary goals of the KASA program.  On the one hand, it is intended to make the review of the CMC section of NDAs,

Final ANDA Submission Guidance Published Today

The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format”(here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents.

There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix A of the document. 

FDA Takes Action on Opioids – Approves Final REMS

Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.”  And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products.  The FDA stated in its new release (here):

This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.  

FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal,