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. 

Martin Shimer Reviews Patents and Exclusivity

In a CDER Conversation piece entitled Patents and Exclusivities for Generic Drugs, Captain Martin Shimer, Deputy Direction, Division of Legal and Program Support, Office of Generic Drugs (OGD), briefly outlines various issues with patents, patent certifications and describes that various types of exclusivity that must be dealt with.

Patents are pretty straight forward,

Ricki Chase, M.S., Director, Lachman Consultants, to Present at American Pharma Outsourcing Summit

Ricki Chase, Director, Compliance Practice, will be presenting at the American Pharma Outsourcing Summit taking place September 27th and 28th, 2017 at the Doubletree by Hilton Boston North Shore. Ricki will be presenting on the Regulatory Hazards of Outsourcing, and will cover the following areas:

  • Approving products on a batch-by-batch basis
  • Establishing laboratory controls
  • Training employees in current GMPs
  • Having appropriate test procedures designed to assure standards
  • Examining compliance services that are available to you

Her presentation will be taking place on Tuesday,

Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to date,

FDA Announces Outsourcing Compounders Fees

The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.

Compounders Outsourcing Fees FY 2018

Establishment

Small Business*

$5,364

Non-Small Business

$17,364

Re-inspection Fee

$16,093

* To qualify revenue must be less than $1,000,000 for all sites and affiliates

The Notice states that “FY 2018 registration period for outsourcing facilities starts on October 1,

Shame Letters from FDA- Will They Work?

The new Commissioner of FDA, Scott Gottlieb, M.D., has been moving very quickly since assuming his post. In a recent announcement reported by RAPS in its Regulatory Focus (here), he indicated FDA’s upcoming plans to “begin releasing letters that FDA sends to brand drug companies when generics question the agency on whether they should be able to obtain samples of the brand drugs necessary to produce generic versions.”

Many of these drugs are provided to patients through restricted distribution programs in which the drugs are sent from a specialty pharmacy directly to the patient. 

UGA’s Wided Najahi-Missaoui Granted First Women in Pharma Scholarship (iSpeak blog, ISPE, September 8, 2017)

Wided Najahi-Missaoui, MS, PharmD, doesn’t know the meaning of the word “can’t.” Since arriving in the United States from Tunisia in 2000, she has earned two graduate degrees (a close friend says she collects degrees like others collect stamps), and accolades. Her mentor, Dr. Michael Griffith Bartlett, who is Professor and Director–BS Program at the University of Georgia (UGA) College of Pharmacy,

PDUFA VI Fee Structure and Fees Announced – Gulp!

In a Federal Register (FR) notice published today (here), the FDA announced that the base amount for the prescription drug user fee (PDUFA) program for new drugs would be $878,590,000, plus another $22,415,658 from something called the “capacity planning adjustment”, which is based on the elements the Agency is using to calculate costs (see list below) ,

Will September Bring a Rush of ANDAs?

Remember when GDUFA I first started and there was a huge number of ANDAs submitted prior to the October 1 implementation date to avoid paying the ANDA fee?  Remember when OGD changed its stability requirement in June 2014 and there were 635 ANDAs submitted prior to the implementation of the new stability requirements?  Well, October 1,

Official August ANDA Approvals and Receipts Reported

We were close with our September 6th post (guess) but there were a few more approval actions reported in the official statistics that were released Friday September 8 in the afternoon.  OGD approved 60 ANDAs and tentatively approved 17 ANDAs for a total approvals action of 77.  There was also a spike in Complete Response Letters (CRLS) where OGD reported the issuance of 155 CRLs,

August Unofficial Approval Figures Not What Industry Had Hoped 

 

Looking at the FDA’s “All Approvals” list (here)  and slugging through supplements and originals for both ANDAs and NDAs, it looks like OGD efforts in August will yield about 57 approvals (the 7th lowest so far in the first 11 months of FY 2017). Also, though OGD tentatively approved (what looks to be like) 16 ANDAs for a total approvals action of 73,

OGD Delivers on First of Two Documents – Early!

Friday, September 1, 2017, the FDA issued MaPP 5200.14, a 43-page document that describes the Office of Generic Drugs’ internal policy and procedures for evaluating an ANDA for initial receipt as substantially complete for “receipt” (filing) purposes. We previously posted about this document here.

The MaPP also outlines the Refuse-to-Receive (RTR) limit on the types of deficiencies that will result in an RTR action,

David G. Lonza, B.S. Engineering, new Head of EU at Lachman Consultant Services, Inc.

We are pleased to announce that David Lonza has accepted the position of Head of EU at Lachman Consultants, effective September 1, 2017.

David Lonza joined Lachman Consultants in August 2016, in the role of Deputy Advisor to the President / CEO – Strategic Initiatives. David’s expertise includes servicing pharmaceutical / biopharmaceutical / biotech clients to meet International Regulatory challenges and Operational Readiness.