European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 107

Food and Drug Administration Side effects Pharmaceutical Leads 107

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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FDA Food and Drug Administration Physicians Safety 52

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.

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Food and Drug Administration Recruitment FDA Patients 52

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Food and Drug Administration Prescription Media FDA 98

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

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Pharmaceutical Food and Drug Administration Manufacturing FDA 127

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma. Current FDA guidance.

Pharma 40

Pharma Food and Drug Administration Medicine Patients 40

Clarify Health

NOVEMBER 9, 2022

However, some communities have historically been underrepresented in clinical research due to barriers like a lack of access, awareness, and trust in drug development processes. Patient-centric approach: Seeking patient input throughout drug development processes can be critical to the success of pharma.

Pharma 40

Pharma Food and Drug Administration Patients Medicine 40