FDA uses the term ‘Unapproved Drugs’ to refer to any drug that is marketed in the U.S. without FDA approval. There are hundreds, maybe thousands of these drugs in the U.S.. We have written about the efforts of FDA to remove them from the market. But also FDA has devoted a lot of resources to [...]
Archive for December, 2009
Getting Unapproved Drugs (DESI, etc.) Approved
Published December 22nd, 2009 in 505(b)(2) Issues. 0 Comments505(b)(2) Approval Standards – Referenced Studies
Published December 22nd, 2009 in Uncategorized. 0 CommentsAwareness of current FDA and its Division standards is important when preparing a new submission. A basic premise for a 505(b)(2) submission to the Agency is that the application contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by [...]
Questions and Answers on the topic of Authorized Generics
Published December 21st, 2009 in ANDA's and How to:. 0 CommentsWhat would be the regulatory path for an Authorized generic, in general?
Authorized Generics (AG) are prescription drugs that are produced by the NDA holder and marketed under a private label, at generic prices. This circumstance typically presents itself when the NDA holder still has patent protection for the product on the market. Authorization of a [...]
The FDA issued a draft guidance “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers (PCID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting” on July 13, 2009. This PCID guidance focuses on the use of inks, pigments, flavors and other physical-chemical identifiers that can be used by manufacturers of solid oral dosage forms (SODF) [...]
