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.

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.

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.  

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,

Verification Systems Under DSCSA Draft Guidance Issues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of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of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

Close-up of unrecognizable laboratory worker viewing statistical data while analyzing result of DNA test

The Importance of Trending During Laboratory Investigations

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness and effectivity of corrective action and determining whether there are any underlying cause/s for noted repeat incidents.

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,

Female chemist at work in laboratory.

Reduced Testing, but Not Reduced Expectations

Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory.  However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically sound.

Macro photo of tooth wheels with COMPLIANCE, REGULATIONS, STANDARDS, POLICIES and RULES words imprinted on metal surface

Bending, Breaking or Moving On: FDA Expands on its 2018 Compounding Policies Priorities

On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could potentially cause harm to patients.

The Devil is in the Details:  Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state).  

Where There is Smoke, There is Fire!

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ).  This included mention of a guidance on the use of botanicals and the availability of Agency tools for expedited development (i.e.,

Awareness And Precision Are Key To Manufacturing Data Integrity

The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory.

The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the data compliance issues that have plagued the laboratories are relevant to areas such as manufacturing.

Simplifying the Complex Generics

During the afternoon session at the first annual GRx+Biosims Meeting held in Baltimore, MD, from September 5-7, 2018, a panel discussion was held to deliberate over aspects that are important to consider when developing a complex generic drug product. The panel consisted of FDA as well as generic industry representatives. GDUFA II provides drug manufacturers with several tools to assist in the development of complex generic drug products including enhanced communication opportunities with FDA and opportunities for innovative approaches in developing a complex generic drug.