Compliance

27
Aug
Question mark with speech bubble on blue background

What It Is May Not Be What It Is!

In a Federal Register notice (here) that will publish on Monday, August 30th, the FDA announced that it “is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc.”  Breckenridge waived its opportunity for hearing on the proposed withdrawal. What makes this instance so […]

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10
Aug

Limited, Inordinate, and Extended Can Kicking?

On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]

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09
Aug

Have an Approved NDA or ANDA for a Contrast Agent or Other Similar Device? Better Read This!

In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]

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22
Jul
Businessman Walking Into The City

FDA Field Alert Reports (FARs) far from Clear – Maybe This Will Help

The FDA issued its final guidance on Field Alert Reports (FARs) today (here).  This guidance finalizes the draft guidance of the same title issued on July 19, 2018. FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent.  I can’t tell you how many times […]

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21
Jul
Digital or electronic thermometer with high temperature 98,6 Fahrenheit in doctors hand. Doctor or nurse in protective PPE suit, face mask, safety googles and rubber gloves demonstrates temperature caused by covid 19, coronavirus or Sars-Cov-2

Domestic Inspections Back to Normal – Mission Critical Still for Foreign In-person Reviews

With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work?  Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]

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01
Jul

Expiration Date Extensions for Critical Drugs on the Shortage List

FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list.  The current list (here) contains 343 entries  Most products have had their expiration dates extended by one year from the labeled expiration date. The list provides information to providers to verify that the firm had submitted […]

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14
Jun

Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic […]

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03
Jun

FDA Publishes Four Guidances on Supply Chain Security Issues

The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]

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27
May

Is This the Beginning of Withdrawal of the Withdrawal of the Unapproved Drug Initiative?

In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]

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30
Apr
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Important ISPE Meeting on Quality Risk Management Sustainability

On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management.  Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]

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