Articles
Following are recent articles on pharma and regulatory topics by FDAMap experts. If there are any particular topics/areas that you would like more information on, please email us at info@fdamap.com.
The 505(b)(2) Drug Development Pathway
The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products.
Resolving Scientific Disputes with FDA
The US Food and Drug Administration (FDA) is a science-based organization that makes decisions based primarily upon thorough and transparent review of the scientific information provided by applicants, existing regulations and previous decisions on similar cases.
The Promise of Biogenerics: Hope and Hype
The year 2007 can be seen as the year when generic biologics came to the forefront of discussions in regulatory, scientific and business circles.
Biosimilars: Past, Present and Future
Facing steep increases in healthcare costs, US legislators are making a concerted effort to find new ways to reduce them.
Developing Botanical Products from India for the US Market
Nonetheless, with only 10% of the Earth’s esti – mated 250,000 species of plants considered medicinal, botanicals are the “sleeping giant” of drug devel – opment.
Energizing Innovation
Former UK Prime Minister Harold Macmillan once said, “to be alive at all involves some risk.” This statement is especially apt for a biomedical product development enterprise.
An FDA Audit Is Good for You
Audits by the US Food and Drug Administration (FDA) are perhaps the most intimidating of all events at a regulated facility.
Forecasting for Success: The Power of Regulatory Gap Analysis
With the ever-changing regulatory environment and rapid developments in science, it is hard to keep track of the development strategy for a biomedical product.
Generics Industry Becoming More Competitive and Profit Margins Shrinking
With generic industry becoming more competitive and profit margins shrinking, Indian firms should take lead in global new product development
Designing a Global Product Development Strategy
Pharmaceutical products are truly global in nature—not only in terms of usage but also in terms of the strategic location of different development activities.
Strategies for Implementing the New GMPs for Dietary Supplement
Dietary supplements have been in the news a lot of late, mostly for the wrong reasons. Last October, the US Food and Drug Administration (FDA) reported that in 2010 there were three times as many dietary supplement recalls as over-the-counter (OTC) and prescription drug recalls combined.
Global Development of an Innovative Medical Device for the US Market
Creating a new medical device based on new technology is a daunting task. This is particularly true for medical devices that target life-threaten – ing conditions and that could potentially pose a high risk to the patients if not used appropri – ately, namely Class III devices.
Meeting With FDA Can Increase the Probability of Product Approval
Formal meetings with reviewers at the US Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking market – ing approval in the US.
Risks and Benefits of Conducting Preclinical Studies in the Global Setting
It is generally accepted that the preclinical stud – ies needed for first-in-man clinical studies usually take one to three years and cost up to $10 million USD, and the preclinical studies needed for market approval application cost about $70–$90 million.
Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms
From its modest start about 30 years ago as an alternative to academic institutions for laboratory and clinical work, outsourcing has grown into a $16 billion industry in the US alone.
Small Business–Big Opportunities
There are two ways of looking at today’s biomedical industry. There is the doomsday scenario based upon dwindling revenues, increasing competition from generics and pipelines drying up, leading to corresponding stock plunges and job cuts.
SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance
Written standard operating procedures (SOPs) are the foundation of any drug development, testing, manufacturing and marketing program.
Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval
The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval.
Developing Traditional Chinese Medicines as Botanical Drugs for the US Market
Therapeutic products derived from medici – nal plants have been used throughout the history of mankind. The use of herbs for treating a variety of ailments has been described in the oldest of human civiliza – tions.
