FDA-Mandated Label Changes Guidance Gives Insight to Potential ANDA Applicants Requirements to Seek Label Changes

FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013. Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues. That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling. It could also require a change to a REMS program or patient information sheet.

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.

A Flair for the PLAIR

, 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 Today the contents of those documents have been incorporated into a Draft Guidance

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.

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.

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.

SCOTUS Gets It Right Again – A Big Win for Generic Companies

The Supreme Court of the United States (SCOTUS) again confirmed that labels for generic products must be the same as the innovator drug that they copy. In addition, SCOTUS determined that the claim of design defects claim in a product liability case cannot be asserted against a generic because the generic product must have the same active ingredient(s), dosage form, route of administration and strength as the product that it copies.

FDA Means Business on Unapproved Drugs – If You Don’t Believe It, Just Wait and See!

At the urging of the FDA, the Department of Justice (DOJ) filed suit against Sage Pharmaceuticals of Louisiana for the marketing of unapproved new drugs. The action comes after numerous warnings and a 2000 injunction against the firm for marketing two unapproved drugs. Failure to recognize that the FDA really meant what it said landed the company and two of its officers in hot water.