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Turtles Get A Reprieve!

By Bob Pollock Jul 25, 2013 FDA

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.

Jul

A Flair for the PLAIR

By Bob Pollock Jul 24, 2013 Compliance FDA Generics Regulatory Affairs

, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet and a Question and Answers document. Today the contents of those documents have been incorporated into a Draft Guidance

Jul

FDA Aims to Secure Photo Rights Under FDASIA

By Bob Pollock Jul 22, 2013 News

The FDA’s assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel. The agency constitutes refusal

Jul

Making Progress Under GDUFA – Well, Not Quite Yet!

By Bob Pollock Jul 16, 2013 FDA Generics Regulatory Affairs

We have seen recent articles in which both FDA and Office of Generic Drugs (OGD) are touting their progress made under the Generic Drug User Fee Act of 2012 (GDUFA). But we are almost 10 months into year one of the program and hiring is just really ramping up.

Jul

Proposed Measures to Clarify FDA’s Import and Inspection Authority

By Bob Pollock Jul 15, 2013 News

The FDA moved to close a glaring gap in the agency’s import powers Friday, issuing a proposed rule that grants detention authority for drugs.

Jul

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

By Bob Pollock Jul 15, 2013 FDA Generics Regulatory Affairs

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.

Jul

Big Duh! Patent Settlements Save Consumers and the Government Money

By Bob Pollock Jul 10, 2013 FDA Generics Regulatory Affairs

The Generic Pharmaceutical Association (GPhA) yesterday released a study showing that patent settlements netted the U.S. healthcare system savings of $25.5 billion dollars over the time period 2005-2012.

Jul

What is FDASIA?

By Bob Pollock Jul 09, 2013 FDA Regulatory Affairs

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.

Jul

Well, What a Fine Kettle of Fish This Is!

By Bob Pollock Jul 08, 2013 FDA Generics Regulatory Affairs

We heard it was coming ever since the Department of Justice hinted the FDA was contemplating a change to permit generic application holders to revise their labeling to make safety changes. Something the Supreme Court actually said generic companies could not do in the Mensing and Bartlett decisions.

Jun

Raptor’s Procysbi Receives 7 Year Orphan Drug Exclusivity

By Bob Pollock Jun 27, 2013 FDA Regulatory Affairs

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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