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Pharmaoffer Cookie Policy

 

 

Pharmaoffer uses cookies and similar technologies to help provide, protect, and improve the Pharmaoffer Platform. This policy explains how and why we use these technologies and the choices you have.
A cookie is a small data file that is transferred to your device (e.g. your phone or your computer). For example, a cookie could allow us to recognize your browser, while another could store your preferences. There are two types of cookies used on the Pharmaoffer Platform: (1) “session cookies” and (2) “persistent cookies.” Session cookies normally expire when you close your browser, while persistent cookies remain on your device after you close your browser, and can be used again the next time you access the Pharmaoffer Platform.
We also use other technologies with similar functionality to cookies, such as web beacons, pixels, mobile identifiers, and tracking URLs, to obtain Log Data (as described in the Privacy Policy). For example, our email messages may contain web beacons and tracking URLs to determine whether you have opened a certain message or accessed a certain link.

 

 

Why Pharmaoffer Uses These Technologies

We use these technologies for a number of purposes, such as:

  • To enable you to use and access the Pharmaoffer Platform and the Payment Services.
  • To enable, facilitate and streamline the functioning of and your access to the Pharmaoffer Platform.
  • To better understand how you navigate through and interact with the Pharmaoffer Platform and to improve the Pharmaoffer Platform.
  • To serve you tailored advertising (such as on the Pharmaoffer Platform, emails and on third-party websites).
  • To show you content (e.g., advertisements) that is more relevant to you.
  • To monitor and analyze the performance, operation, and effectiveness of the Pharmaoffer Platform and Pharmaoffer advertisements.
  • To enforce legal agreements that govern use of the Pharmaoffer Platform.
  • For fraud detection and prevention, trust and safety, and investigations.
  • For purposes of our own customer support, analytics, research, product development, and regulatory compliance.


Cookies

When you visit our websites we place cookies on your computer. Cookies are small text files that websites send to your computer or other Internet-connected device to uniquely identify your browser or to store information or settings in your browser. Cookies allow us to recognize you when you return. They also help us provide a customized experience and can enable us to detect certain kinds of fraud. In many cases you can manage cookie preferences and opt-out of having cookies and other data collection technologies used by adjusting the settings on your browser. All browsers are different so visit the “help” section of your browser when to learn about cookie preferences and other privacy settings that may be available. Please note that if you choose to remove or reject cookies or clear local storage this could affect the features, availability, and functionality of our websites.

Pixel Tags and Web Beacons

Pixel tags and web beacons are tiny graphic images and small blocks of code placed on website pages, ads, or in our emails that allow us to determine whether you performed a specific action. When you access these pages, or when you open an email, the pixel tags and web beacons let us know you have accessed the web page or opened the email. These tools help us measure response to our communications and improve our web pages and promotions.

Server Logs and Other Technologies

We collect many different types of information from server logs and other technologies. For example, we collect information about the device you use to access our website, your operating system type, browser type, domain, and other system settings, as well as the language your system uses and the country and time zone where your device is located. Our server logs also record the IP address of the device you use to connect to the Internet. An IP address is a unique identifier that devices require to identify and communicate with each other on the Internet. We may also collect information about the website you were visiting before you came to our website and the website you visit after you leave our site. These tools help us improve user experience and deliver our services.

Device Information

We may use device-related information to authenticate users. For example, we may use your IP address, browser information, or other data provided by your browser or device to identify the device being used to access our platform. We may also use these device-related techniques for associating you with different devices that you may use to access our content including for fraud-protection purposes and to better target advertising.

Third Parties

We may also allow certain business partners to place these technologies on the Pharmaoffer Platform. These partners use these technologies to (1) help us analyze how you use the Pharmaoffer Platform, such as by noting the third party services from which you arrived, (2) market and advertise Pharmaoffer services to you on the Pharmaoffer Platform and third-party websites, (3) help us detect or prevent fraud or conduct risk assessments, or (4) collect information about your activities on the Pharmaoffer Platform, other sites, and/or the ads you have clicked on.
For example, to help us better understand how people use the Pharmaoffer Platform, we work with a number of analytics partners, including Google Analytics. To prevent Google Analytics from using your information for analytics, you may install the Google Analytics Opt-Out Browser by clicking here.
Third parties may also use such tracking technologies to serve ads that they believe are most likely to be of interest to you and measure the effectiveness of their ads both on the Pharmaoffer Platform and on other websites and online services. Targeting and advertising cookies we use may include Google, and other advertising networks and services we use from time to time. For more information about targeting and advertising cookies and how you can opt out, you can visit the Network Advertising Initiative’s opt-out page, the Digital Advertising Alliance’s opt-out page, or http://youronlinechoices.eu.
To opt out of Google Analytics for display advertising or customize Google display network ads, you can visit the Google Ads Settings page. To the extent advertising technology is integrated into the Pharmaoffer Platform and you opt-out of tailored advertising, you may still receive advertising content. In that case, the advertising content will just not be tailored to your interests. Also, we do not control any of these opt-out links and are not responsible for the availability or accuracy of these mechanisms.

Third Party Social Plugins

The Pharmaoffer Platform may use social plugins provided and operated by third parties, such as Facebook’s Like Button. As a result of this, you may send to the third party the information that you are viewing on a certain part of the Pharmaoffer Platform. If you are not logged into your account with the third party, then the third party may not know your identity. If you are logged in to your account with the third party, then the third party may be able to link information or actions about your interactions with the Pharmaoffer Platform to your account with them. Please refer to the third party’s privacy policies to learn more about its data practices.

Your Choices

Most browsers automatically accept cookies, but you can modify your browser setting to decline cookies by visiting the Help portion of your browser’s toolbar.
Your mobile device may allow you to control cookies through its settings function. Refer to your device manufacturer’s instructions for more information.
If you choose to decline cookies, some parts of the Pharmaoffer Platform may not work as intended or may not work at all.


 

 

 

 

 

What is the FDA?
Food and Drug Administration

David Blok | Posted on October 23, 2023

Introduction

Have you ever wondered who ensures the medications you take are safe and effective? Enter the FDA. Serving as the guardian of public health, the FDA plays a pivotal role in the pharmaceutical industry. But what exactly is the FDA, and why does it matter to industry professionals?

Brief History of FDA

The FDA, or the U.S. Food and Drug Administration, has its roots tracing back to the early 20th century. Established in 1906, its primary mission was to protect consumers from misbranded and adulterated foods, drugs, and cosmetics. Over the decades, its responsibilities expanded, making it the powerhouse regulator it is today.

The Role of FDA in the Pharmaceutical Industry

Imagine the pharmaceutical landscape without a watchdog. Risky, right? The FDA steps in to fill this crucial role.

Ensuring Drug Safety

Safety is paramount. Before any drug hits the market, it undergoes rigorous scrutiny by the FDA. This ensures that the benefits of the drug outweigh any potential risks.

Overseeing Clinical Trials

Clinical trials are the backbone of drug development. The FDA oversees these trials, ensuring they're conducted ethically and that the data generated is accurate and unbiased.

Regulation of Over-the-Counter and Prescription Drugs

Not all drugs are created equal. While some are available over the counter, others require a doctor's prescription. The FDA classifies and regulates these medications, ensuring that over-the-counter drugs are safe for public consumption without expert supervision, while prescription drugs are administered under a healthcare professional's guidance.

The Path to FDA Approval

Major steps in the FDA’s drug review process

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Animal testing

Sponsor tests drug on multiple animal species to gather information about safety and efficacy.

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IND application

Sponsor submits an Investigational New Drug (IND) application, which includes initial findings and plans for human trials, for FDA review.

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Clinical trials

Sponsor undertakes three phases of clinical trials, progressively increasing the number of volunteers, to determine the drug's side effects, safety, and effectiveness.

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NDA application

Sponsor submits a New Drug Application (NDA), which includes clinical trial findings, for FDA review.

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Label review

FDA ensures appropriate information for both health-care professionals and consumers is included on the drug label.

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Approval

FDA either approves or rejects the drug for the U.S. market.

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Post-marketing monitoring

Sponsor submits periodic safety updates to the FDA.

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Source: U.S. Food and Drug Administration.

    The FDA Approval Process

    The journey of a drug from the lab to the pharmacy shelf is intricate. Let's demystify the FDA's approval process.

    Phases of Clinical Trials

    A drug undergoes multiple phases of clinical trials before it's deemed safe:

    1. Phase I: Safety evaluation with a small number of participants.
    2. Phase II: Efficacy and side-effect assessment in a larger group.
    3. Phase III: Large-scale testing to confirm effectiveness and monitor side effects.
    4. Phase IV: Post-marketing surveillance.

    To gain a deeper understanding of the intricacies of clinical trials, especially in relation to Active Pharmaceutical Ingredients (API), consider reading 'EVERYTHING YOU NEED TO KNOW ABOUT API CLINICAL TRIALS'.

    Post-Approval Surveillance

    The FDA's job doesn't end with drug approval. It continuously monitors drugs for any adverse effects, ensuring long-term safety.

    Key Terms Associated with the FDA

    Let's decode some jargon associated with the FDA.

    New Drug Application (NDA)

    An NDA is the formal step a drug sponsor takes to request that the FDA consider a drug for commercial marketing and sale.

    Generic Drug

    A generic drug is a medication that offers the same therapeutic benefits as its brand-name counterpart but is sold under a different name.

    Biologics License Application (BLA)

    For biological products like vaccines, a BLA is submitted instead of an NDA. It's the FDA's green light for production and sale.

    The Impact of FDA Decisions on the Pharmaceutical Industry

    The FDA wields considerable influence in the pharmaceutical world. Its decisions can make or break a drug's future. From approval timelines affecting a company's stock price to recalls that might tarnish a brand's reputation, the FDA's verdicts are closely watched by industry stakeholders.

    To delve deeper into the challenges pharmaceutical companies might face due to FDA decisions, consider reading 'Navigating the FDA’s Warning Letter: A Comprehensive Guide'. 

    FDA's Global Influence

    While the FDA is a U.S. entity, its impact is felt globally. Many countries look to the FDA's decisions as a benchmark. When the FDA approves a drug, it often paves the way for approvals in other nations.

    Criticisms and Controversies

    No institution is without its critics. The FDA, given its pivotal role, has faced its share of controversies. From accusations of being too slow in approving life-saving drugs to concerns about potential conflicts of interest, it's essential to understand the challenges the FDA navigates.

    Conclusion

    The FDA, a guardian of public health, plays an indispensable role in the pharmaceutical industry. Its decisions, grounded in rigorous scientific evaluation, aim to ensure that the drugs we consume are safe and effective. As professionals in the pharmaceutical industry, understanding the FDA's functions and processes empowers us better to navigate the complex landscape of drug development and marketing.

    What's the difference between the FDA and the EMA?

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    The FDA is the regulatory body for the U.S., while the EMA (European Medicines Agency) oversees drug approvals in the European Union.

    How long does the FDA approval process typically take?

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    While timelines vary, it often takes around 8-12 years from drug discovery to FDA approval.

    Are FDA-approved drugs always safe?

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    The FDA ensures drugs have benefits that outweigh risks. However, like all medical interventions, no drug is entirely without risk.

    Can a drug lose its FDA approval?

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    Yes. If new safety concerns arise or if the drug's benefits no longer outweigh its risks, the FDA can revoke its approval.