August 2015

27
Aug

Draft Biosimilar Naming Guidance Hits the Street

FDA released its long awaited Guidance on naming of Biosimilar products (Nonproprietary Naming of Biological Products – Guidance for Industry) today. In what is not too much of a surprise, especially after the first approved biosimilars name had a suffix (Zarxio, filigrastim-sndz), the FDA opted for most biosimilar products to have a suffix. In addition, FDA is proposing to assign a suffix to the originator biologic products.

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18
Aug

MaPP to Nowhere Now has Coordinates to Find the Treasure

or those of you who troll the CDER web page, you may have noticed that the Office of Generic Drugs (OGD) posted a revision of MaPP 5200.3 entitled “Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications” last night. OGD’s issuance of revision 1 of the MaPP clearly provides industry with much of what they have been asking for.

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11
Aug

FDA Clarifies Issues Regarding Outsourcing Pharmacies

The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.”  Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether […]

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04
Aug

Compounding Pharmacies – Is Anyone in Compliance???

Imagine an industry where approximately 40% of firms inspected receive Warning Letters and nearly 100% receive substantial FDA Form 483 observations. Publically available information indicates that the FDA has issued 19 Warning Letters to compounding Pharmacies just in 2015 and 41 and counting to date in the last two and a half years.  There have […]

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03
Aug

It’s Official – A New Guidance Document for Analytical Method Validations

  Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here)  which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”. The new Guidance covers the required information relating to […]

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