05
Jul
Countdown numbers flip counter. Vector isolated 0 to 9 retro style flip clock or scoreboard mechanical numbers set black on white

OGD Updates the Other May 2022 Statistics

On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]

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01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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29
Jun

Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.”  The program is designed to “facilitate and expedite” review of promising […]

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28
Jun

Looking for ANDA Candidates with No Generic Competition?

The FDA recently published an updated version of the Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (here).  The list is broken down into two parts that identify either prescription or over‑the‑counter drugs (that require an ANDA as the subject of approval), and each of these respective lists is broken down into two […]

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23
Jun

Beta‑Lactam Antibiotics 2013 Guidance for Preventing Cross Contamination Hits the Street

The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products.  Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]

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20
Jun

With One Controversial Drug for Alzheimer’s on the Market, Another’s Study Did Not Impress

There is no question that the Alzheimer’s drug Aduhelm has stirred up a lot of controversary.  The action that CMS took related to reimbursement for the drug for Medicare patients and the initial yearly projected cost soured many stakeholders on the product, from prescribers to patients, as well as caregivers and healthcare providers, not to […]

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16
Jun

Engaging with FDA: Hidden Gems at the FDLI Annual Conference Day 1

The first day of the Food and Drug Law Institute’s Annual Conference started with an excellent keynote address from FDA Commissioner Dr. Robert Califf, who underscored the importance of the FDA engaging with industry to evaluate the promise (as well as risks) of new technology and medicinal products.  Part of that dialogue happens at the individual […]

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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion.  People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation.  Thus, quality metrics were held tightly close to the chest of business leaders.  Deming identified this […]

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10
Jun

Moles Can Be Dangerous (and Not Just in Your Yard) – FDA Warns Consumers that Danger Lurks in Unapproved Products

The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons.  It warns that there is no FDA-approved OTC product for removing moles or skin tags.  Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]

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