24
Sep
Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor Image

Compounding vs. FDA Approved Product Presents a Conundrum Regarding the Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor

Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]).  The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints.  Ms. […]

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19
Sep
Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Image

Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Them Immediately Visible

I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).  The latter two listings […]

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18
Sep
Petition Guidance Published Image

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that […]

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18
Sep
Extraneous Chromatographic Peaks Image

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations.  In 2016, […]

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13
Sep
Question Marks on Blackboard

Silver Spring – We Have a Problem! August Approval Numbers Don’t Add Up!

OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here).  However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative […]

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10
Sep
Doctor holding a clipboard with Safety first, Medical concept

FDA Denies Public Citizen Petition Asking for a Moratorium on All New Opioid Approvals

In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products.  The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies […]

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27
Aug

Effective Post Market Supplier Strategy for Combination Products

A combination product, which is a combination of a drug or biologic with a device delivery constituent part, are typically designed, developed, and maintained under a robust manufacturing process. This article is targeted for companies that have existing combination products on the market or are prepping their quality management systems to be compliant with the […]

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27
Aug

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]

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27
Aug

Considerations for Analytical Method Validation Life Cycle Controls

A question that may be raised by industry professionals is, “How does the upcoming ICH Q14 guideline impact the methods that I currently use?” The FDA’s July 2015 Guidance for Industry: “Analytical Procedures and Method Validation for Drugs and Biologics” references analytical method development, the use of statistical tools during method validation, and life cycle […]

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30
Jul
stack of one hundred dollars notes

FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020.  The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020. The medical device fees are provided in the […]

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