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Innovation in immuno-oncology: Leading companies in in-vitro T-cell activation

Pharmaceutical Technology

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: In-vitro T-cell activation. Immatics is the leading patent filer in in-vitro T-cell activation.

In-Vitro 130
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AI in IVF: a fertile field

Pharmaceutical Technology

Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Fairtility also claims the product reduces the time taken for each IVF cycle by 30 hours. in 2000 to 12.3%

In-Vitro 264
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FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

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FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

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It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law Blog

Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

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Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALID

FDA Law Blog

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” FDA, which was not invited to participate, would surely have concurred. This seems to have been the outcome that many lawmakers desired.

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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device.