The Lachman Blog

03
Jun

Use of Animal Rule Discussed in Revised FDA Guidance

FDA typically requires safety and efficacy to be demonstrated in humans, but there are times when exposure of humans to toxic therapeutic substances may be impractical and ethically impossible (e.g., antidote for nerve gas treatment, nuclear threat, biological, chemical or substance that would otherwise causea life-threating condition or poisoning [e.g., snake venom, virus, industrial chemicals]). The FDA has released a newly revised update to its previously issued 2009 Guidance on this topic.

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02
Jun

April OGD Statistics Just Published – Let’s Look at the Numbers a Bit Differently

Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs’ (OGD) progress, but this month, let’s just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.

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28
May

Buyer Beware! That Legitimate Looking Prescription Site May Cost You Your Health

In a coordinated enforcement action involving the FDA, US Customs and Border Patrol, along with international agencies like Interpol and enforcement and regulatory bodies from 111 countries, action was taken against web sites that “sell unapproved prescription drugs to US consumers.” This is part of an ongoing effort of a program termed Operation Pangea.

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28
May

Salonpas Pain Relief Patch Petition Does Not Provide Full Relief Sought by Petitioner

In a petition response issued on May 23, 2014to Hisamitsu Pharmaceutical Company, the FDA partially approved, but mostly denied the requests of the NDA holder for Salonpas (menthol and methyl salicylate 3%, 10%) Patch in a petition submitted on January 6, 2010. While the response did not come as much of a surprise relative to the NDA holders asks, the fact that the petition was submitted in 2010 and is just now being responded to is somewhat a matter of conjecture.

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14
May

FDA to Give Industry Heads Up on Finalizing Q&A Guidance on Stability Testing for ANDAs

With about one month to go before the Office of Generic Drugs (OGD) new stability requirements go into effect, a one hour briefing by invitation will be held on May 15, 2014 to discuss the new requirements. It will likely touch on the Draft Questions and Answers Guidance ANDA: Stability of Drug Substance and Drug Products, with (hopefully) an emphasis on any clarifications or revisions that have been made to the final guidance (to be published soon).

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14
May

Revised Q&A on Stability Issued – Clarity Provided on Some Issues But Questions Still Remain

The Revised Q&A Guidance on stability for ANDA drug products and drug substances was posted on the CDER web page today (here). While the Agency did a good job in terms of some of the clarifications requested by questions submitted in response to the initial document, there are still some unanswered questions that may require clarification to the clarifications!

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