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,

August Official Approvals and Receipts Released as OGD Approaches Record Year

The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday.  August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017.  These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.

Fast, Fast, Fast, Everybody Wants Fast – But There Could be a High Cost to Pay

I know that the flag was raised in victory when the first generic of EpiPen was approved.  Not many people outside those familiar with the plight of complex generic products could understand how or why it took so long for a generic version of that product to make it through the approval process.  This is discussed in an interesting article by Avik Roya,

Facility Issues Sink Minor Amendment Designation

Historically, the Office of Generic Drugs (OGD) has classified major/minor amendments on the time necessary for review.  Minor amendments required minimal review, while major amendments required extensive review.  If there was an issue with a facility (e.g., cGMP), the old Deficiency Letters (DLs) and Complete Response Letters (CRLs) used to state that the firm should not respond to the letter until the facility issues have been resolved. 

Go Fund Me Page Contemplated for Headstone at Grave Site of 505(j)(2)(C) Petitions

I just searched through 643 hits on Regulations.gov for 505(j)(2)(C) petitions.  Granted, all of those were not actually for ANDA suitability petitions under the citation listed above, but most were.  The good news is that the industry still submits these petitions (an ANDA suitability petition requests a change from a reference listed drug in strength,

Nominations to FDA Bulk Drug List for 503B Compounders Provides Three Strikes

In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason.

Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare finished-drug compounded product directly from the active pharmaceutical ingredient. 

Halfway Through the Month for Generic Approvals and Where Are We?

July was an amazing month for generic drug approvals with a total of 126 (ninety-six full approvals and thirty tentative approvals).  We were wondering whether such a figure would be sustainable or whether it might empty the “ready-to-approve” bucket at OGD.  We know the effort it takes to pump out that many applications and refill the pipeline and get those approval packages lined up for the next month. 

FDA Determines That Danocrine Is OK, But Not for All Indications

The FDA responds to numerous petitions each year asking for determinations as to whether products that have been withdrawn or discontinued from marketing have been so removed for safety or efficacy reasons.  Such determination is necessary to permit the continued marketing of other approved ANDAs that cite a Reference Listed Drug (RLD) as their basis for submission,

Chew on This!

Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here).  The document provides advice to sponsors of NDAs, ANDAs, some chemistry supplements, INDs, and manufacturers of non-application chewable products on the critical attributes that should be identified and quantified for chewable immediate release tablets.

NDA and BLA Resubmission Review Timelines Outlined in Revised MaPP

The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today.

The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues.  The document identifies resubmissions to NDAs, BLAs, and efficacy supplements as either Class 1 or Class 2 submissions. 

PDUFA Fees for FY 2019 Announced

A Federal Register Notice (here) released today announced the new Prescription Drug User Fees (PDUFA fees) for FY 2019.  And while there had been a modest increase, the fact is the there is an increase signifies that there is little expectation that fees will retreat anytime in the next few years. 

Biosimilar User Fees Announced for FY 2019

The Federal Register notice published today (here) announces the FY 2019 biosimilar user fees.

The initial Biologic Product Development (BPD) fee is due when the sponsor submits an Investigational New Drug (IND) application to the Agency or within five days after the FDA grants the first BPD meeting.  The annual BPD fee is assessed the following FY and each year until the sponsor submits a marketing application or until the sponsor notifies the FDA that it is no longer participating in the program;