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What can be submitted for reconsideration to the FDA?
Occasionally, applicants may disagree with an FDA decision regarding one of their submissions. A recent guidance published by the U.S. FDA..
Types of ANDA amendments
Recently, the U.S. Food and Drug Administration released a guidance to explain how assessment goals are set for amendments to...
Challenges of building national medical stockpiles
Countries often establish national medical stockpiles to prepare for public health crises and unexpected drug shortages...
How Estonia Became a Startup Hub
Thanks to its push towards digitalizing business services, Estonia has become an attractive hub for entrepreneurs, IT professionals, and ...
Ensuring Drug Safety with Risk Evaluation and Mitigation Strategies (REMS)
One of the pharmaceutical industry’s top priorities is to ensure the safe use of medications without compromising their efficacy...
Estonia: A European hub for scientific research
Estonia is an excellent example of how investment in innovation can drive economic and research growth. On average, 227 PhD degrees are...
Hidden Costs Across the Pharmaceutical Supply Chain
The rising costs of U.S. healthcare affect all participants in the supply chain, from manufacturers to patients...
Two critical factors that affect pharmaceutical supply chains
Comparing bids is a critical step since it affects the overall production cost and product margins. In our experience ...
The Medicare price negotiation: a problem and an opportunity for the generics industry
This autumn, the U.S. Secretary of Health and Human Services (HHS) has finally begun negotiating prices for 10 Medicare Part D drugs as...
Key changes in the generics industry could prevent drug shortages
The growth of the generics market has produced impressive economic benefits for the United States. The Association for Accessible...
From Words to Action: Defining Company Values That Work
At The J. Molner Company, company values are not just a business buzzword. We define company values as tangible, measurable, and ...
How Organizational Culture Surveys Can Build a Better Workplace
Employees who feel engaged, motivated, and aligned with the values of their workplace are more likely to contribute to the success of ...
Summer Days: An Introduction to the Sunniest Estonian Tradition
Summer is a season perfect for relaxation, as the Estonian tradition of “summer days” attests. Summer days are events organized...
IVRT: A cost-effective study that fulfills dermatological bioequivalence testing requirements
Recent updates in FDA guidelines open a cost-saving opportunity for pharma companies looking to fulfill dermatological bioequivalence...
Navigating the FDA Reporting Categories with The J. Molner Company
At The J. Molner Company, we have revamped our portfolio of services to support pharmaceutical companies navigating FDA reporting...
Drug shortages in Europe: a preventable crisis?
Across the EU, demand is surging as pharmacy shelves become empty. Can future shortages be prevented? Let’s take a look. Recently,...
The inflation crisis shakes up the pharmaceutical industry
Pharmaceutical companies are now dealing with inflation, a problem that used to be considered long gone. With rising rent and food...
Company-wide leave time - Why every business should do it
As the Great Resignation hit businesses around the world, clever managers addressed their teams’ burnout with a novel solution:...
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