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Verification Systems Under DSCSA Draft Guidance Issues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of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of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,

Close up of asthma inhaler

Of Drugs and Devices

The DIA Complex Drug-Device Combination Workshop is being held at the Sheraton Silver Spring during October 9‑10, 2018.  The first day of the conference dealt with the regulatory aspects of the generic submissions for these kinds of products, and discussions on clinical aspects related to complex generics, with a focus on inhalation products.

The meeting was well-attended,

Female chemist adds drops of blue substance into test tubes, lab research

How Current is Your Stability Program?

A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing.  During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing.

Neither the current guidance ICH Q1A(R2) “Stability Testing of New Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.  

Hamster running on an exercise wheel

Controlled Correspondence Made Easier, But Watch Out

On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA.  The process is further explained here, including how to register for use of the portal.  This could help speed CCs to the Agency, but it is the problem with what happens to some once they reach the Agency that has raised some industry eyebrows,

Fran Zipp Elected Vice Chair of ISPE International Board of Directors

LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The newly elected Board includes LCS’ own CEO and President,

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