The Lachman Blog

25
Jul

Turtles Get A Reprieve!

In a Federal Register Notice to publish today, the FDA is issuing a direct Final Rule that eliminates the destruction of certain turtle eggs and turtles less than 4 inches by or under the supervision of an FDA investigator (see FR notice here).
The original regulation with was designed to stop the spread of turtle-related salmonellosis (particularly to children) banned the sale or possession of certain turtle eggs or live turtles with a carapace length of less than 4 inches.

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15
Jul

Will My Satisfactory Inspection Status Expire Before My ANDA Is Approved??

The effective “expiry” of a satisfactory inspection and the need to re-inspect a facility before granting of ANDA approval has become a practical problem for the generic industry, which carries the risk of potentially significant consequences including marketing delays, loss of projected revenues and forfeiture of exclusivity entitlement in a worse-case scenario. In light of this continuing challenge, and in light of some existing ambiguities regarding FDA inspection policy, Lachman contacted CDER’s Office of Compliance to determine its current policy regarding conduct of inspections required in support of approval of ANDAs.

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09
Jul

What is FDASIA?

The Food and Drug Administration Safety and Innovation Act, more commonly known as FDASIA, was signed into law on July 9, 2012 (Public Law 112-144) and has been getting increased publicity as the provisions in the Act are getting more action and traction.

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27
Jun

Raptor’s Procysbi Receives 7 Year Orphan Drug Exclusivity

In a previous post, we reported that FDA had finalized its revised Orphan Drug Regulations. Those regulations further explained how and when a firm may be eligible for a second period of ODE for the same drug and the same indication. FDA exempted quality of life issues as a factor in determining significant clinical improvement; however, they allowed as a factor for consideration products that significantly improved patient compliance.

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