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.

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.

Nine First Time Generic Approvals in July

Of the 47 ANDAs approved in July 2015, there were 9 first-time approved generic products. These represent the first time that the generic product was made available in the marketplace and demonstrates the Office of Generic Drug’s (OGD) commitment to getting first generics into the marketplace at the first available date.

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 to Register as Outsourcing Facilities Under Section 503B of the Federal Food,

Office of Generic Drugs’ July Numbers Are In

The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions.  While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD.

The number of receipts in July was 40,

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 been numerous recalls due to lack of sterility assurance,

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”.