October 2014

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Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products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 Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.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.

Oct

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

By Bob Pollock Oct 01, 2014 FDA Regulatory Affairs

Prev 1 2

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?

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

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