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On November 23, 2016, EFSA will present its draft guidance document on allergenicity of genetically modified ("GM") plants at a meeting in Parma, Italy.

On October 1, 2015, the EMA published a draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins for consultation.

The European Union has adopted new regulations on clinical trials that will come into force in 2016.

The European Commission and the Scientific Committee on Emerging Newly Identified Health Risks have published guidance on determining potential health effects of using nanomaterials in medical devices.

The Bundesgerichtshof asked the Court of Justice whether the device may be classified as defective based solely on evidence that quality control checks on devices of the same model disclosed a potential defect.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the first advanced therapy medicinal product containing stem cells for approval in the European Union.

On October 23, 2015, the CHMP has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.

A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection...

Last week Bexis published a Legal Backgrounder for the Washington Legal Foundation, entitled "Recent Rulings Establish New Beachheads For Preemption In Drug And Device Product Liability Litigation."

On May 1, CDRH announced the eSubmissions Pilot Program, a new pathway to guide medical device manufacturers through constructing and submitting their 510(k) materials electronically without having to submit a hard copy or a compact disc.

The FDA is inviting medical device industry, academia, and health care facilities to participate in its Experiential Learning Program for medical devices.

According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare...

The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis.

This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer...

On March 23, 2015, District Judge Charlene Honeywell from the U.S. Middle District of Florida in Tampa issued a favorable claim construction ruling for FLH client Shire Pharmaceuticals.

On April 14, 2016, CMS will host a call on the "Data Element Library" that will facilitate exchange and use of post-acute care assessment data under the Improving Medicare Post-Acute Care Transformation (IMPACT) Act.

FDA amended the animal drug regulations to reflect approval actions for new animal drug applications and ANADAs during September and October 2014.

The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration.