Size Does Matter!

In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising.

The document clarifies the relationship between the size (and not type size) of the proprietary name and established name in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name. 

New Metrics and Format for OGD Stats, Just Filled in For October 2017

The new statistical report of the Activities of the Generic Drug Program (FY 2018) Monthly Performance (here) was posted on December 4, 2017. There are many new statistics being captured and to tell the truth I am not sure exactly what they all mean but I think I’ve got it straight.  Please take a look at the above report and if you disagree with my reading on any of these metrics please give me a shout out.

FDA Heard You, But Did They Really Hear You?

The FDA today posted a revised draft guidance (here)  on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II.  We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong.

Many in the industry have complained that with the stated purpose of the PFC to identify all facilities used in the proposed application the Agency could determine whether a facility inspection was needed. 

First Month of GDUFA II Looks Good for Approvals

While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement.  It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs.  These numbers may go up a bit if some stragglers show up when the numbers are scrubbed for the official totals.

Final GDUFA I Activities Report Issues – How Does the 5-Years Look

Well after the first 5 years of GDUFA I, we now have a comparative look at all 5 years for various metrics reported by the FDA in their Activities Report of the Generic Drug Program.  In the chart below the 5- year highs are bolded and some trends can be seen. For instance, the number of post CRL meetings was highest in year two of the GDUFA program. 

Do You Owe the FDA Money?

Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees.  The FDA published arrears lists today and there are a lot of folks on those lists.  If there is an error or if you need to pay the fee you should either rectify the situation quickly or pay the owed fee. 

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – A Must Read!

On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II.  There are a number of hidden landmines relative to fee payment, especially relative to the program fee and reminder information about requests to withdraw an ANDA and its impact on the tier designation for the Program Fee,

New MaPP – Shuts Door on ANDA Review Status Requests from Other than Authorized Representative

The Office of Generic Drugs (OGD) has long taken the position that calls from multiple industry representatives about the same application to different OGD review staff or senior staff do nothing but waste the time of OGD.  This is definitely accurate; however, those multiple calls in the past were made because information was difficult (if not impossible) to get,

Final FY 2017 ANDA Numbers Are In – Holy Cow!

The FDA posted its final approvals and receipts numbers for FY 2017 today.  We thought there might be a blip in receipts due to firms trying to beat the GDUFA II fee clock which took effect on October 1, 2017, and we were right.  OGD received a whopping 202 ANDAs in September.  This was not a record month in FY 2017,

Major and Minor Amendments Under GDUFA II – Read Me Loud and Clear

The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements.  The system for classifying the goal dates has been simplified from a tiered system under GDUFA I to a standard and priority review system under the new GDUFA iteration.

RTR a New Q&A Guidance!

OGD has released a new Q&A document relative to refuse-to-receive issues.  I must be quite frank, there were some questions and their answers of which I was not aware.  Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior to filing.

Synthetic Peptide Products Eligible for ANDA Submission – Maybe!

After years of internal FDA debate, the FDA issued a guidance yesterday which was designed to assist an ANDA applicant in “determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food,

Rare Pediatric Disease and Tropical Disease Priority Fees – Where the Air is Rare!

The voucher program for rare pediatric diseases and tropical diseases was established to encourage firms to develop drug products for both of these categories.  The voucher is awarded when such an NDA is approved, and that voucher can be used on another NDA by the same company or transferred (sold) to a third party to use on any other NDA products.