Annual Report on Postmarketing Requirements and Commitments Shows Continued Progress

Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications.  In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.

Holiday Turkey Dinner

The Turkey Thanksgiving Blog

Every year at this time, we all ponder and are asked about what we are thankful for.  It goes without saying, family, good health for all we love and peace on earth.  We are all blessed in some way or another and we all have that one thing that stands out.  Make your standout thing special this year!

Official October OGD Numbers Are In, and Yes,  Another Record!

While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here)  on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2.  OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!

An Old Friend, Newly Designed, Comes Back to the OTC Asthma Market

I remember in the “old days” back in the 70’s, before most of you may have been born, Primatene Mist containing epinephrine, was a life saver as an OTC medicine for mild asthma.  Why did it disappear from pharmacy shelves?  Because it contained chlorofluorocarbons (CFCs) as a propellant.  As you know, CFCs were banned, and phased out of the market in 2011 in an effort to help protect the ozone layer under the Montreal Convention.

35 years old man is practicing running at the field. He is preparing for the championship

OGD Off to A Good Start in FY 2019

If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019.  The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October.  Two big days so far this month were October 12th,

Hand with classic stopwatch

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,

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,

A 3D representation of the word final hanging on a plain white background. The word is hanging from binder paper…

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. 

Yellow warning sign screwed to a brick wall to warn about a threat. In the middle of the panel, there…

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,