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Genentech - A Member of the Roche GroupGenentech - A Member of the Roche Group

Process Overview

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Approval day at Genentech comes with a cacophony of joyful noise. We're not exactly sure when it started, but when a medicine is approved by the FDA, we ring bells. And we hear the FDA does too. For us, it's a recognition of the work that got us here, and it's a celebration of being able to offer a new treatment option to a patient who needs it. For you, let it be a celebration of completing the Making Medicine story. So join us. Ring that bell.

Protecting the Medicine


The package is more than a wrapper when it comes to making medicine. It's protection. We put very special care into making sure our medicines can safely make it to their destination.

We've reached a milestone, but there's still more to do.

Ongoing Safety Initiatives

Pivotal clinical trials evaluate if a medicine is safe and effective enough to receive FDA approval for marketing. Even after approval, there is still a lot to learn about the medicine. For example, understanding the particular efficacy and safety profile of a medicine for pediatric uses or in the elderly.

In addition, doctors and patients may use our medicines in ways we have not already studied. So, we often conduct ‘real world’ studies to assess the emerging risks and benefits of our medicine in larger or more diverse populations.

Learn more about Ongoing Safety Initiatives

Exploring Other Uses

Medicines can have more than one single use. They may be used in different ways for the same disease or across diseases. A good example of this is cancer, where the biology often tells us that a medicine for treating one type of cancer could potentially work in another.

Approval initiates additional research by doctors worldwide. We may opt to partner with doctors at universities and hospitals to support these “investigator-sponsored trials.” And in doing so, understand the potential and limitation of a new medicine across may different diseases, dosing regimens and drug combinations.

Learn more about Exploring Other Uses

Supporting Access

Approval signals our ability to deliver our medicines to the patients who need it. But beyond the physical delivery, when one of our medicines is prescribed, we have a dedicated team of people who can help patients understand the range of support services we provide.

We offer coverage and co-pay support as well as patient assistance to make sure that healthcare coverage isn’t a barrier to patients seeking our medicines. Whenever possible, we make sure that people can get the medicines they need, regardless of their ability to pay.

Learn more about Supporting Access

Learn more at gene.com


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