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Combination Products: What’s New?
A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the...
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New FDA Guidances for January 2013
FDA has already released a handful of new guidances to start off the year 2013. They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product...
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The Changing Landscape of Postmarketing Safety Reporting
Drugs are approved for marketing on the basis of clinical trials that are, generally speaking, carried out on relatively small numbers of people. The goal of these trials are to identify the risks...
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Everything You Need to Know About Priority Review Vouchers: Part 1 of 2
The Basics, History, and Record of the Priority Review Voucher Program The Basics If your company’s goals include funding pipeline development or increasing speed to market you should, at least, be...
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Everything You Need to Know About Priority Review Vouchers: Part 2 of 2
The Rare Pediatric Disease PRV, the Difference in the PRVs, and the Future of the Program The Rare Pediatric Disease Priority Review Voucher (If you haven’t read Part 1 yet, start there first!) A new...
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FDA’s New Guidances for February 2013
Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the...
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The Dawn of a New Clinical Paradigm in the Land of the Rising Sun
A major milestone in the use of stem cells in human therapies was reached in February of 2013. An ethics committee has authorized the first in-human study utilizing induced pluripotent stem cells...
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New FDA Guidances for March 2013
FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in...
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New Guidance: Formal FDA Meetings for Biosimilar Product Development
On 01 April 2013, the FDA released its fourth guidance regarding the development of biosimilar products: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants....
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New FDA Guidances for April 2013
There were many new Guidances out in April. Notably, changes in postmarketing periodic safety reporting are discussed in this guidance. See CATO’s take on some of the changes in postmarket reporting...
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U.S. Pediatric Product Development
In the United States, there are two regulations in place regarding pediatric trials and related incentives: the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act...
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New FDA Guidances for May 2013
FDA released 10 guidances in May, including two Q & A guidances, which I always find helpful (Charging for Investigational Drugs Under an IND and Expanded Access to Investigational Drugs for...
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New FDA Guidances for June 2013
FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA. Look for a review of...
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Finally! The Draft Guidance on Breakthrough Therapies
On 25 Jun 2013, FDA released the long-awaited guidance on breakthrough therapies: “Expedited Programs for Serious Conditions-Drugs and Biologics”. Since the breakthrough therapy program was mandated...
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New FDA Guidances for July 2013
Another month with lots of new and updated guidances released. Two guidances highlight clinical design considerations for specific therapies: Antibacterial Therapies for Patients With Unmet Medical...
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New FDA Guidances for August 2013
New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device...
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Who’s at Work at FDA Today?
For the first time in 17 years, the U.S. government has entered a shutdown, shuttering all nonessential employees and activities until Congress can reach a budget agreement. What does that mean for...
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New FDA Guidances for September 2013
September was a big month for CDRH Guidances. Both the final Mobile Medical Applications Guidance and the much awaited Guidance on the Unique Device Identification Database were released. More...
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Recap: U.S. Conference on Rare Diseases and Orphan Products
The 2013 US Conference on Rare Diseases and Orphan Products, sponsored by the Drug Information Association (DIA) and the National Organization for Rare Disorders (NORD), was held on 07 – 09 October in...
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The Future of Medical Product Approval in South Africa
In response to the thalidomide tragedy of the early 1960s, the South African government wanted to ensure that only safe and effective drugs were used in the treatment of patients in their country....
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