Navigating the Latest Regulatory Changes in Biotech

The biotech industry is experiencing significant regulatory changes aimed at enhancing safety, transparency, and affordability. In the U.S., the FDA plans to regulate laboratory-developed tests (LDTs) as medical devices, addressing concerns about test reliability and patient safety. Meanwhile, the Biden Administration's new policy on march-in rights for government-funded drug patents aims to tackle high drug prices but has sparked controversy over potential impacts on innovation.

In Europe, the EU is updating its pharmaceutical regulations to promote drug accessibility and sustainability. The European Medicines Agency (EMA) has revised its transparency rules for clinical trials, improving public access to trial data and fostering greater transparency for patients and healthcare professionals.

Biotech companies must stay informed and adapt to these changes, developing robust quality management systems and fostering collaboration to balance innovation with compliance.

For a deeper dive into these regulatory changes, visit Pharmaceutical Technology and MRL Recruitment.

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