New and Revised Bio Guidances Issued by OGD

The Office of Generic Drugs is publishing thirty-one new and fifteen revised bioequivalence guidances according to the pre-publication notice that appeared in the Federal Register today (here).  The official FR notice is scheduled to publish on September 17, 2019, but a quick check reveals that the new and revised guidance documents are already available today (September 16th) on the Product-Specific Guidances for Generic Drug Development (here).

OGD Updates July 2019 Metrics

The Office of Generic Drugs provided an update late last night to its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here).  Not too many surprises, but there are a couple of numbers that are of interest.

Let’s start with refuse-to-receive (RTR) actions.  There were only two RTR actions in July (both for standard review applications),

Urgent Drug Listing Issue – Check Your Product Status!!!!

Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice  due to publish on Wednesday (pre-publication notice here).

The Notice indicates registrant’s responsibilities as follows:

Each registrant must list all drugs it manufactures for commercial distribution within 3 days of initial registration (21 CFR 207.45).  

Pregabalin Approvals Hit the Approval Trail, but Why So Late?

According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019.  However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019.  This got my mind working to try to figure out why the
17-day (June 30 fell on a Sunday) delay occurred,

Potential Label Carve Out to Antidepressant Appears OK to FDA

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here  ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction would not make an ANDA product less safe or effective than the reference listed drug.

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. 

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,

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 drug substances that can be used to compound drug products under Section 503A of the FD&C Act even though they are not the subject of an applicable USP or NF monograph or a component of an FDA approved drug product (the 503A Bulks List).” Oxtriptan was specifically excluded from that list.

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). 

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.