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The FCC is considering whether to expand available radio frequency (RF) for implanted and body-worn wireless devices, but manufacturers disagree on whether additional RF is needed.
The SEC has taken another step toward reforming its Sarbanes-Oxley (SOX) reporting and auditing requirements by requesting public comments on proposed changes.
The European Medicines Agency (EMEA) has issued separate guidelines on clinical investigations of medicinal products used in the treatment of sepsis and weight control, as well as two other major medical conditions.
Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) have released a revised draft labeling order for medicines under the joint Australia New Zealand Therapeutic Products Authority.
The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BiMo) program.
Medical product marketers are facing increasingly restrictive environments in a number of states, experts said at a recent conference on marketing compliance.
The SEC has taken an intermediate step in its effort to reform Sarbanes-Oxley (SOX) reporting and auditing requirements by requesting public comments on proposed changes.
The FDA should step back from its policy of requiring risk management plans (RMP) is part of the drug approval process, according to a senior official — indicating a major change in the agency’s thinking on drug safety.