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U.S. Food and Drug Administration SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

Case Study SWOT Analysis Solution

Case Study Description of U.S. Food and Drug Administration


Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure.

Authors :: Robert F. Higgins, Richard G. Hamermesh, Virginia A. Fuller

Topics :: Organizational Development

Tags :: , SWOT Analysis, SWOT Matrix, TOWS, Weighted SWOT Analysis

Swot Analysis of "U.S. Food and Drug Administration" written by Robert F. Higgins, Richard G. Hamermesh, Virginia A. Fuller includes – strengths weakness that are internal strategic factors of the organization, and opportunities and threats that Drug Biologic facing as an external strategic factors. Some of the topics covered in U.S. Food and Drug Administration case study are - Strategic Management Strategies, and Organizational Development.


Some of the macro environment factors that can be used to understand the U.S. Food and Drug Administration casestudy better are - – digital marketing is dominated by two big players Facebook and Google, banking and financial system is disrupted by Bitcoin and other crypto currencies, talent flight as more people leaving formal jobs, customer relationship management is fast transforming because of increasing concerns over data privacy, increasing household debt because of falling income levels, there is backlash against globalization, technology disruption, wage bills are increasing, central banks are concerned over increasing inflation, etc



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Introduction to SWOT Analysis of U.S. Food and Drug Administration


SWOT stands for an organization’s Strengths, Weaknesses, Opportunities and Threats . At Oak Spring University , we believe that protagonist in U.S. Food and Drug Administration case study can use SWOT analysis as a strategic management tool to assess the current internal strengths and weaknesses of the Drug Biologic, and to figure out the opportunities and threats in the macro environment – technological, environmental, political, economic, social, demographic, etc in which Drug Biologic operates in.

According to Harvard Business Review, 75% of the managers use SWOT analysis for various purposes such as – evaluating current scenario, strategic planning, new venture feasibility, personal growth goals, new market entry, Go To market strategies, portfolio management and strategic trade-off assessment, organizational restructuring, etc.




SWOT Objectives / Importance of SWOT Analysis and SWOT Matrix


SWOT analysis of U.S. Food and Drug Administration can be done for the following purposes –
1. Strategic planning using facts provided in U.S. Food and Drug Administration case study
2. Improving business portfolio management of Drug Biologic
3. Assessing feasibility of the new initiative in Organizational Development field.
4. Making a Organizational Development topic specific business decision
5. Set goals for the organization
6. Organizational restructuring of Drug Biologic




Strengths U.S. Food and Drug Administration | Internal Strategic Factors
What are Strengths in SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

The strengths of Drug Biologic in U.S. Food and Drug Administration Harvard Business Review case study are -

High switching costs

– The high switching costs that Drug Biologic has built up over years in its products and services combo offer has resulted in high retention of customers, lower marketing costs, and greater ability of the firm to focus on its customers.

Low bargaining power of suppliers

– Suppliers of Drug Biologic in the sector have low bargaining power. U.S. Food and Drug Administration has further diversified its suppliers portfolio by building a robust supply chain across various countries. This helps Drug Biologic to manage not only supply disruptions but also source products at highly competitive prices.

Effective Research and Development (R&D)

– Drug Biologic has innovation driven culture where significant part of the revenues are spent on the research and development activities. This has resulted in, as mentioned in case study U.S. Food and Drug Administration - staying ahead in the industry in terms of – new product launches, superior customer experience, highly competitive pricing strategies, and great returns to the shareholders.

Learning organization

- Drug Biologic is a learning organization. It has inculcated three key characters of learning organization in its processes and operations – exploration, creativity, and expansiveness. The work place at Drug Biologic is open place that encourages instructiveness, ideation, open minded discussions, and creativity. Employees and leaders in U.S. Food and Drug Administration Harvard Business Review case study emphasize – knowledge, initiative, and innovation.

Strong track record of project management

– Drug Biologic is known for sticking to its project targets. This enables the firm to manage – time, project costs, and have sustainable margins on the projects.

High brand equity

– Drug Biologic has strong brand awareness and brand recognition among both - the exiting customers and potential new customers. Strong brand equity has enabled Drug Biologic to keep acquiring new customers and building profitable relationship with both the new and loyal customers.

Ability to lead change in Organizational Development field

– Drug Biologic is one of the leading players in its industry. Over the years it has not only transformed the business landscape in its segment but also across the whole industry. The ability to lead change has enabled Drug Biologic in – penetrating new markets, reaching out to new customers, and providing different value propositions to different customers in the international markets.

Superior customer experience

– The customer experience strategy of Drug Biologic in the segment is based on four key concepts – personalization, simplification of complex needs, prompt response, and continuous engagement.

Innovation driven organization

– Drug Biologic is one of the most innovative firm in sector. Manager in U.S. Food and Drug Administration Harvard Business Review case study can use Clayton Christensen Disruptive Innovation strategies to further increase the scale of innovtions in the organization.

Training and development

– Drug Biologic has one of the best training and development program in the industry. The effectiveness of the training programs can be measured in U.S. Food and Drug Administration Harvard Business Review case study by analyzing – employees retention, in-house promotion, loyalty, new venture initiation, lack of conflict, and high level of both employees and customer engagement.

Operational resilience

– The operational resilience strategy in the U.S. Food and Drug Administration Harvard Business Review case study comprises – understanding the underlying the factors in the industry, building diversified operations across different geographies so that disruption in one part of the world doesn’t impact the overall performance of the firm, and integrating the various business operations and processes through its digital transformation drive.

Diverse revenue streams

– Drug Biologic is present in almost all the verticals within the industry. This has provided firm in U.S. Food and Drug Administration case study a diverse revenue stream that has helped it to survive disruptions such as global pandemic in Covid-19, financial disruption of 2008, and supply chain disruption of 2021.






Weaknesses U.S. Food and Drug Administration | Internal Strategic Factors
What are Weaknesses in SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

The weaknesses of U.S. Food and Drug Administration are -

Need for greater diversity

– Drug Biologic has taken concrete steps on diversity, equity, and inclusion. But the efforts so far has resulted in limited success. It needs to expand the recruitment and selection process to hire more people from the minorities and underprivileged background.

Slow to harness new channels of communication

– Even though competitors are using new communication channels such as Instagram, Tiktok, and Snap, Drug Biologic is slow explore the new channels of communication. These new channels of communication mentioned in marketing section of case study U.S. Food and Drug Administration can help to provide better information regarding products and services. It can also build an online community to further reach out to potential customers.

Lack of clear differentiation of Drug Biologic products

– To increase the profitability and margins on the products, Drug Biologic needs to provide more differentiated products than what it is currently offering in the marketplace.

Interest costs

– Compare to the competition, Drug Biologic has borrowed money from the capital market at higher rates. It needs to restructure the interest payment and costs so that it can compete better and improve profitability.

Slow to strategic competitive environment developments

– As U.S. Food and Drug Administration HBR case study mentions - Drug Biologic takes time to assess the upcoming competitions. This has led to missing out on atleast 2-3 big opportunities in the industry in last five years.

Low market penetration in new markets

– Outside its home market of Drug Biologic, firm in the HBR case study U.S. Food and Drug Administration needs to spend more promotional, marketing, and advertising efforts to penetrate international markets.

No frontier risks strategy

– After analyzing the HBR case study U.S. Food and Drug Administration, it seems that company is thinking about the frontier risks that can impact Organizational Development strategy. But it has very little resources allocation to manage the risks emerging from events such as natural disasters, climate change, melting of permafrost, tacking the rise of artificial intelligence, opportunities and threats emerging from commercialization of space etc.

Compensation and incentives

– The revenue per employee as mentioned in the HBR case study U.S. Food and Drug Administration, is just above the industry average. Drug Biologic needs to redesign the compensation structure and incentives to increase the revenue per employees. Some of the steps that it can take are – hiring more specialists on project basis, etc.

High dependence on star products

– The top 2 products and services of the firm as mentioned in the U.S. Food and Drug Administration HBR case study still accounts for major business revenue. This dependence on star products in has resulted into insufficient focus on developing new products, even though Drug Biologic has relatively successful track record of launching new products.

High cash cycle compare to competitors

Drug Biologic has a high cash cycle compare to other players in the industry. It needs to shorten the cash cycle by 12% to be more competitive in the marketplace, reduce inventory costs, and be more profitable.

Aligning sales with marketing

– It come across in the case study U.S. Food and Drug Administration that the firm needs to have more collaboration between its sales team and marketing team. Sales professionals in the industry have deep experience in developing customer relationships. Marketing department in the case U.S. Food and Drug Administration can leverage the sales team experience to cultivate customer relationships as Drug Biologic is planning to shift buying processes online.




Opportunities U.S. Food and Drug Administration | External Strategic Factors
What are Opportunities in the SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis


The opportunities highlighted in the Harvard Business Review case study U.S. Food and Drug Administration are -

Identify volunteer opportunities

– Covid-19 has impacted working population in two ways – it has led to people soul searching about their professional choices, resulting in mass resignation. Secondly it has encouraged people to do things that they are passionate about. This has opened opportunities for businesses to build volunteer oriented socially driven projects. Drug Biologic can explore opportunities that can attract volunteers and are consistent with its mission and vision.

Finding new ways to collaborate

– Covid-19 has not only transformed business models of companies in Organizational Development industry, but it has also influenced the consumer preferences. Drug Biologic can tie-up with other value chain partners to explore new opportunities regarding meeting customer demands and building a rewarding and engaging relationship.

Low interest rates

– Even though inflation is raising its head in most developed economies, Drug Biologic can still utilize the low interest rates to borrow money for capital investment. Secondly it can also use the increase of government spending in infrastructure projects to get new business.

Learning at scale

– Online learning technologies has now opened space for Drug Biologic to conduct training and development for its employees across the world. This will result in not only reducing the cost of training but also help employees in different part of the world to integrate with the headquarter work culture, ethos, and standards.

Leveraging digital technologies

– Drug Biologic can leverage digital technologies such as artificial intelligence and machine learning to automate the production process, customer analytics to get better insights into consumer behavior, realtime digital dashboards to get better sales tracking, logistics and transportation, product tracking, etc.

Loyalty marketing

– Drug Biologic has focused on building a highly responsive customer relationship management platform. This platform is built on in-house data and driven by analytics and artificial intelligence. The customer analytics can help the organization to fine tune its loyalty marketing efforts, increase the wallet share of the organization, reduce wastage on mainstream advertising spending, build better pricing strategies using personalization, etc.

Redefining models of collaboration and team work

– As explained in the weaknesses section, Drug Biologic is facing challenges because of the dominance of functional experts in the organization. U.S. Food and Drug Administration case study suggests that firm can utilize new technology to build more coordinated teams and streamline operations and communications using tools such as CAD, Zoom, etc.

Creating value in data economy

– The success of analytics program of Drug Biologic has opened avenues for new revenue streams for the organization in the industry. This can help Drug Biologic to build a more holistic ecosystem as suggested in the U.S. Food and Drug Administration case study. Drug Biologic can build new products and services such as - data insight services, data privacy related products, data based consulting services, etc.

Buying journey improvements

– Drug Biologic can improve the customer journey of consumers in the industry by using analytics and artificial intelligence. U.S. Food and Drug Administration suggest that firm can provide automated chats to help consumers solve their own problems, provide online suggestions to get maximum out of the products and services, and help consumers to build a community where they can interact with each other to develop new features and uses.

Harnessing reconfiguration of the global supply chains

– As the trade war between US and China heats up in the coming years, Drug Biologic can build a diversified supply chain model across various countries in - South East Asia, India, and other parts of the world. This reconfiguration of global supply chain can help, as suggested in case study, U.S. Food and Drug Administration, to buy more products closer to the markets, and it can leverage its size and influence to get better deal from the local markets.

Manufacturing automation

– Drug Biologic can use the latest technology developments to improve its manufacturing and designing process in Organizational Development segment. It can use CAD and 3D printing to build a quick prototype and pilot testing products. It can leverage automation using machine learning and artificial intelligence to do faster production at lowers costs, and it can leverage the growth in satellite and tracking technologies to improve inventory management, transportation, and shipping.

Better consumer reach

– The expansion of the 5G network will help Drug Biologic to increase its market reach. Drug Biologic will be able to reach out to new customers. Secondly 5G will also provide technology framework to build new tools and products that can help more immersive consumer experience and faster consumer journey.

Lowering marketing communication costs

– 5G expansion will open new opportunities for Drug Biologic in the field of marketing communication. It will bring down the cost of doing business, provide technology platform to build new products in the Organizational Development segment, and it will provide faster access to the consumers.




Threats U.S. Food and Drug Administration External Strategic Factors
What are Threats in the SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis


The threats mentioned in the HBR case study U.S. Food and Drug Administration are -

New competition

– After the dotcom bust of 2001, financial crisis of 2008-09, the business formation in US economy had declined. But in 2020 alone, there are more than 1.5 million new business applications in United States. This can lead to greater competition for Drug Biologic in the Organizational Development sector and impact the bottomline of the organization.

Shortening product life cycle

– it is one of the major threat that Drug Biologic is facing in Organizational Development sector. It can lead to higher research and development costs, higher marketing expenses, lower customer loyalty, etc.

Aging population

– As the populations of most advanced economies are aging, it will lead to high social security costs, higher savings among population, and lower demand for goods and services in the economy. The household savings in US, France, UK, Germany, and Japan are growing faster than predicted because of uncertainty caused by pandemic.

Easy access to finance

– Easy access to finance in Organizational Development field will also reduce the barriers to entry in the industry, thus putting downward pressure on the prices because of increasing competition. Drug Biologic can utilize it by borrowing at lower rates and invest it into research and development, capital expenditure to fortify its core competitive advantage.

Barriers of entry lowering

– As technology is more democratized, the barriers to entry in the industry are lowering. It can presents Drug Biologic with greater competitive threats in the near to medium future. Secondly it will also put downward pressure on pricing throughout the sector.

High dependence on third party suppliers

– Drug Biologic high dependence on third party suppliers can disrupt its processes and delivery mechanism. For example -the current troubles of car makers because of chip shortage is because the chip companies started producing chips for electronic companies rather than car manufacturers.

Increasing wage structure of Drug Biologic

– Post Covid-19 there is a sharp increase in the wages especially in the jobs that require interaction with people. The increasing wages can put downward pressure on the margins of Drug Biologic.

Capital market disruption

– During the Covid-19, Dow Jones has touched record high. The valuations of a number of companies are way beyond their existing business model potential. This can lead to capital market correction which can put a number of suppliers, collaborators, value chain partners in great financial difficulty. It will directly impact the business of Drug Biologic.

Stagnating economy with rate increase

– Drug Biologic can face lack of demand in the market place because of Fed actions to reduce inflation. This can lead to sluggish growth in the economy, lower demands, lower investments, higher borrowing costs, and consolidation in the field.

Technology acceleration in Forth Industrial Revolution

– Drug Biologic has witnessed rapid integration of technology during Covid-19 in the Organizational Development industry. As one of the leading players in the industry, Drug Biologic needs to keep up with the evolution of technology in the Organizational Development sector. According to Mckinsey study top managers believe that the adoption of technology in operations, communications is 20-25 times faster than what they planned in the beginning of 2019.

Instability in the European markets

– European Union markets are facing three big challenges post Covid – expanded balance sheets, Brexit related business disruption, and aggressive Russia looking to distract the existing security mechanism. Drug Biologic will face different problems in different parts of Europe. For example it will face inflationary pressures in UK, France, and Germany, balance sheet expansion and demand challenges in Southern European countries, and geopolitical instability in the Eastern Europe.

Regulatory challenges

– Drug Biologic needs to prepare for regulatory challenges as consumer protection groups and other pressure groups are vigorously advocating for more regulations on big business - to reduce inequality, to create a level playing field, to product data privacy and consumer privacy, to reduce the influence of big money on democratic institutions, etc. This can lead to significant changes in the Organizational Development industry regulations.

High level of anxiety and lack of motivation

– the Great Resignation in United States is the sign of broader dissatisfaction among the workforce in United States. Drug Biologic needs to understand the core reasons impacting the Organizational Development industry. This will help it in building a better workplace.




Weighted SWOT Analysis of U.S. Food and Drug Administration Template, Example


Not all factors mentioned under the Strengths, Weakness, Opportunities, and Threats quadrants in the SWOT Analysis are equal. Managers in the HBR case study U.S. Food and Drug Administration needs to zero down on the relative importance of each factor mentioned in the Strengths, Weakness, Opportunities, and Threats quadrants. We can provide the relative importance to each factor by assigning relative weights. Weighted SWOT analysis process is a three stage process –

First stage for doing weighted SWOT analysis of the case study U.S. Food and Drug Administration is to rank the strengths and weaknesses of the organization. This will help you to assess the most important strengths and weaknesses of the firm and which one of the strengths and weaknesses mentioned in the initial lists are marginal and can be left out.

Second stage for conducting weighted SWOT analysis of the Harvard case study U.S. Food and Drug Administration is to give probabilities to the external strategic factors thus better understanding the opportunities and threats arising out of macro environment changes and developments.

Third stage of constructing weighted SWOT analysis of U.S. Food and Drug Administration is to provide strategic recommendations includes – joining likelihood of external strategic factors such as opportunities and threats to the internal strategic factors – strengths and weaknesses. You should start with external factors as they will provide the direction of the overall industry. Secondly by joining probabilities with internal strategic factors can help the company not only strategic fit but also the most probably strategic trade-off that Drug Biologic needs to make to build a sustainable competitive advantage.



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