12
Jul

Can We Call It the Affirmation of a “Beautiful Friendship”?

FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was […]

Read More
12
Jul

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]

Read More
11
Jul

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live […]

Read More
11
Jul

We Were Close – June Was A Bit Of A Bust

OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing.  We missed the approval actions by one.  OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of […]

Read More
11
Jul

Ready or Not Here They Come – Lab Regulatory Inspections

Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection.  The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories.  The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI).  The anxiety about an impending inspection often triggers […]

Read More
10
Jul

Inactive Ingredient Database Moving Closer to Target GDUFA Upgrade

Today, the FDA issued a draft guidance titled Using the Inactive Ingredient Database (here).  The guidance describes how to use the inactive ingredient database (IID) and its limitations. FDA has been using the IID since 1987 and has committed to updates throughout the year that provide more current and useful information.  Excipients are constantly being […]

Read More
10
Jul

The Yellow Brick Road for Risk Evaluation and Mitigation Strategies

On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions.  The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015.  The update is more of a finalization; the portion of the draft that sets forth the submission procedures for […]

Read More
10
Jul

New MaPP Fully Outlines Process for FDA Safety Label Changes

New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs.  It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act […]

Read More
09
Jul

FDA’s New Weapons to Fight the Opioid Crisis

Yesterday, FDA announced the eligibility of ANDAs submitted for drug products indicated for the emergency treatment of known or suspected opioid overdose, to be granted priority review status (either shorter goal dates, or expedited review without formal reduction of the goal date) under the public health emergency option stated in MAPP 5240.3 (priority criterion number […]

Read More
08
Jul

503A Compounders May Get Another Bulk Substance Permitted, But For Now, Enforcement Discretion

In a Federal Register Notice (here) published today, the FDA announced a Compliance Policy which will exercise enforcement discretion relative to 503A compounders using the bulk drug, Oxitriptan, for compounding oral forms of the drug.  Remember, “FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk […]

Read More