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.

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.

FDA Collection of Information FR Notice Provides Some Interesting Estimates

The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here).  The notice states that:

Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.  

Are We in Harmony Yet?

The Fourth Annual Global Regulatory Affairs CMC Conference was held in Philadelphia on October 29‑30, 2018.  The conference focused on successful developmental and post-market CMC operations and product lifecycle management tactics, based on better understanding of U.S. and global regulatory requirements for small molecules and biologics.

Talking of life -cycle management, the current draft of ICH Q12 loomed large as the deadline for comment by most regulatory bodies of the world is in December 2018.  

Image representing statistics

2018 FY OGD Statistics Finalized

Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here.  There are some interesting figures and comparisons to previous years that are discussed below.

Let’s look at refuse-to-receive (RTR) actions to start.  FY 2018 saw the fewest RTRs since the start of GDUFA.

Metal clean shelves in market. 3d rendering

AG Epinephrine Autoinjectors get 2-Month Expiration Extension to Take Pressure off Interim Shortage

The FDA announced extended use dates for 72 lots of epinephrine autoinjectors.  All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency.   FDA noted in its announcement (here) that it does not expect or require the product to be relabeled with the revised expiration date,

In an Unusual Move, FDA Reopens Comment Period on BE guidance for Sucralfate Suspension

While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule.  Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained.

Verification Systems Under DSCSA Draft Guidance Issues

With many of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of the Agency relative to ensuring that products are legitimate under the DSCSA.

2018 ISPE Pharmaceutical Manufacturing Conference, Managing the Global Pharmaceutical Supply Chain: How Pharmaceutical Quality System (PQS) Ensures Sustainable Compliance, Mumbai, India

In a time that we find ourselves so busy, who has time to attend a conference?  That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators.  

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,

Day 2 is written on sand on a Hawaiian beach

Of Drugs and Devices – The Saga Continues

The DIA Complex Drug-Device Combination Workshop was held at Sheraton Silver Spring on October 9‑10, 2018.  The second day’s discussion was dominated by issues related to transdermal systems and intrauterine devices.  The presenters on the second day were mostly from the FDA, with a few from academia and CROs.  The FDA presenters focused on quality expectations for devices,