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Home » Topics » Regulatory

Regulatory
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U.S., China wrecking balls

Clock is ticking on China-based securities on US exchanges

May 31, 2022
By Mari Serebrov
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
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Drug capsules in petri dish

EMA tackles AMR with revised guidance

May 31, 2022
By Mari Serebrov
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Read More

Regulatory actions for May 31, 2022

May 31, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Almirall, Altesa, Amneal, Eisai, Instil, Revive.
Read More
Brazilian flag

Brazil readies to adopt SaMD regulation

May 27, 2022
By Sergio Held
Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.
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EU flags in front of the Berlaymont building

As EU’s IVDR regs come into force, infrastructure gaps remain

May 27, 2022
By Nuala Moran
“The incomplete in vitro diagnostic regulation (IVDR) poses critical ongoing risks that need urgent resolution,” said Medtech Europe, as it welcomed the coming into force of the new EU regulatory system on May 26. Five years since the publication of the regulation, and after the industry has invested “significant resources into complying with its requirement,” some key elements of the infrastructure “are still not fully operational or even in place,” according to the trade body. “It is critical that all needed infrastructure is put in place and made operational without delay,” said Serge Bernasconi, CEO of Medtech Europe.
Read More
Lumiradx HbA1c test packaging

Lumiradx seals CE mark for HbA1c diabetes test

May 27, 2022
By Catherine Longworth
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
Read More
Illustration of untreated vein (left) vs. vein with Shelfwrap (right)

Venostent’s Selfwrap wins breakthrough device designation

May 27, 2022
By David Godkin
A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.
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US FDA advises on prostate cancer drugs, Canadian imports

May 27, 2022
Among the latest guidances pouring out from the U.S. FDA are ones addressing development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada.
Read More
Drug capsules in petri dish

EMA tackles AMR with revised guidance

May 27, 2022
By Mari Serebrov
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Read More

Regulatory actions for May 27, 2022

May 27, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance, Nanomix.
Read More
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