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FDA Issues Final Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection

By Bob Pollock Oct 24, 2014 Compliance FDA Generics Regulatory Affairs

On October 21, 2014, FDA announced the availability of its Final Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (here). This document finalizes Guidance that was published in draft for comment on July 12, 2013. The Guidance is intended to fulfill FDA’s obligation in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to define the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit inspection, actions that FDASIA established as causing drugs to be adulterated.

Oct

Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals?

By Bob Pollock Oct 23, 2014 FDA Generics Regulatory Affairs

The Office of Generic Drugs (OGD) listed 6 first-to-file (FTF) ANDAs with Paragraph IV (PIV) challenges yesterday. It is interesting to note that all were originally submitted in 2014-the oldest submission date was in April 2014 and the newest in July of this year. We know that OGD gives priority acceptance review to FTF ANDAs and the 2014 dates may signify that the priority acceptance review of PIV submissions is in full swing.

Oct

And Then There Were Three!

By Bob Pollock Oct 20, 2014 FDA Generics Regulatory Affairs

A day after writing a post about abuse-deterrent products and their potential impact on patients, the generic drug industry and the FDA, the Agency approved the third opioid extended-release product with abuse-deterrent information in its labeling approved via a supplemental new drug application, the drug Embeda (morphine sulfate/naltrexone hydrochloride) Extended-release Capsules.

Oct

Continued Complexity Of A High Profile CRO Data Integrity Case

By Bob Pollock Oct 20, 2014 Compliance FDA Generics Regulatory Affairs Science & Technology

While it is well recognized that any pharmaceutical company implicated with data integrity issues could have significant impact on its business and survivability, the impact from a similarly implicated CRO would be even greater as it could severely impact all sponsors’ pending and approved products. A case in point is Cetero/PRACS. Lachman Consultants was hired by a number of Cetero’s sponsors in support of these very labor intensive and highly specialized audits and (we are happy to say) successfully completed many audits for affected studies.

Oct

Abuse-Deterrent Formulations – A Boom or Bust?

By Bob Pollock Oct 17, 2014 FDA Generics Regulatory Affairs

In the case of abuse-deterrent products, the FDA has waded into some deep water and it seems the water continues to deepen. Clarity around what FDA really wants and expects from such products remains murky at best.

Oct

Patients and Pharmacists to be Surveyed by FDA on Their Perception of Differences in Attributes of Generic Products

By Bob Pollock Oct 14, 2014 Compliance FDA Generics Regulatory Affairs

FDA announced in today’s Federal Register (FR) that they will conduct a survey of patients and pharmacists to gain an understanding of both groups’ perception of certain attributes of differences in generic medicines for the same drug product.This survey comes on the heels of Office of Generic Drug Guidance (OGD) on size, shape and color of generic products, issued last December. FDA has received complaints and feedback from numerous patient and health care providers on various aspects related to differences in the physical characteristics of generics when they are initially switched from the brand name product (when initial substitution occurs) as well as when switching to other generic manufacturers of the product on subsequent refills.

Oct

Not All Are Happy with FDA’s Final Guidance on NCE Exclusivity for Combination Products!

By Bob Pollock Oct 10, 2014 FDA Generics Regulatory Affairs

Today, FDA published its final guidance on New Chemical Entity (NCE) Exclusivity Determinations for Certain Fixed-Combination Drug Products. The Guidance comes about 7.5 months after the February 2014 Federal Register notice first announcing the new Agency position was published. While some parties are happy with the decision to award NCE exclusivity if one of the components is a first time approval (the previous Agency position was that if one component had been previously approved, then the combination was not eligible for the 5-year protection), others are crying in their soup (and in Federal Court) about the change.

Oct

FY 2014 Final Statistics for OGD Released

By Bob Pollock Oct 09, 2014 FDA Generics Regulatory Affairs

With a record number of ANDAs received by the Office of Generic Drugs (OGD) and a modern day record low number of approvals, we move into FY 2015 still looking for the bright spot.

Oct

Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

By Bob Pollock Oct 07, 2014 Compliance FDA Generics Regulatory Affairs

With the FDA’s move to reduce the amount of acetaminophen (APAP) for prescription combination products to no more than 325mg per dosage unit completed, FDA seems to be moving into the Over-the-Counter (OTC) arena to help reduce potential overdose or medication errors with liquid APAP products targeted for pediatric patients. Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

Oct

Rare Pediatric Disease Priority Voucher – What Will You Pay for Speed?

By Bob Pollock Oct 01, 2014 FDA Regulatory Affairs

Today, the FDA announced the 2015 fee for the use of a Rare Pediatric Disease Voucher in a Federal Register (FR) notice (here). Created by the FDA Safety and Innovation Act (FDASIA), this program provides a voucher to a sponsor that gains approval for an NDA for a product used to treat an indication that has been classified as a rare pediatric disease. There is a price for use of the voucher and it ain’t cheap-the voucher fee for 2015 is fixed at $2,562,000.

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The Lachman Blog

FDA Issues Final Guidance – Delaying, Denying, Limiting, or Refusing a Drug Inspection

Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals?

And Then There Were Three!

Continued Complexity Of A High Profile CRO Data Integrity Case

Abuse-Deterrent Formulations – A Boom or Bust?

Patients and Pharmacists to be Surveyed by FDA on Their Perception of Differences in Attributes of Generic Products

Not All Are Happy with FDA’s Final Guidance on NCE Exclusivity for Combination Products!

FY 2014 Final Statistics for OGD Released

Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

Rare Pediatric Disease Priority Voucher – What Will You Pay for Speed?

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