Professional Baseball Batter Striking Baseball During Night Game In Stadium

Halfway through the Twenty-Two Reporting Days of July, Are OGD Approval Actions Perking Back Up?

With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month.  These numbers are derived from the FDA’s All Approvals page here.

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective.

Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 therapeutic biopharmaceutical products (TBPs).  

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FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph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 initiated in 2015.

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 to harmonize standards within the industry.  

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 news reporting and sports events in real time.  

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 62 approval actions for June 2019. 

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 REMS revisions and modifications.

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,

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 4).  

A Peek at the June Approval Numbers – Keep Your Hands Over your Eyes!

We reported here that June may be a gloomy month for approval actions.  A few days ahead of the release of the official OGD numbers, it looks like we were on target.  As reported through this morning on FDA All Approvals List (here), OGD had issued 44 full approval actions and 17 tentative approval for a total of 61 approval actions in June.

FDA Issues Two New Labeling Guidances to Aid Sponsors

The FDA announced the availability of two draft labeling guidance documents today.  One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (to help sponsors develop a standard drug abuse and dependences section of the labeling). 

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA).  In December of last year, the FDA published a final guidance as well as a Questions and Answers guidance regarding the complex logistics of this regulatory transition. 

The Agency Speaks to Its Effort for Modernizing FDA’s New Drugs Regulatory Program

Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process.