17
Sep
Red Arrow Moving Down Over Graph Paper Background

September 2021 ANDA Approval Actions Slow Through the First Half of the Month

Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action.  If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]

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08
Sep
Hanging word Q&A

Q&A Guidance on Development of Generic Drugs During the COVID 19 Emergency

Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants.  Remember that the answers […]

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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  This guidance finalizes the draft guidance of the same title issued on July 19, 2018.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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