Environment, health, & safety
With the growing reuse of single-use medical devices, ANA supports improvements in end-of-use product management and research on ethical and safety issues related to…
News
FDA updates safety data for silicone gel-filled breast implants
A new report of data from studies conducted by manufacturers confirms that silicone gel-filled breast implants are “safe and effective when used as intended.”…
FDA proposes new policy for some devices
The U.S. Food and Drug Administration (FDA) has proposed a new policy that reduces premarket notification requirements related to devices that have had their…
FDA changes sunscreen labeling requirements
The U.S. Food and Drug Administration (FDA) has revised requirements for sunscreen labeling. The final rule takes effect by summer 2012. Read more.
FDA releases draft guideline related to nanotechnology
The Food and Drug Administration (FDA) has released “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” a draft guidance document available for…
FDA approves Nulojix for prevention of acute rejection in kidney transplant patients
The U.S. Food and Drug Administration (FDA) has approved Nulojix (belatacept) for prevention of acute rejection in adult patients who have had a kidney…
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration (FDA) has approved the Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal total hip replacement system for patients…
New FDA regulation for improving safety reporting in clinical trials discussed in The New England Journal of Medicine.
The June 8 edition of The New England Journal of Medicine includes “New FDA Regulation to Improve Safety Reporting in Clinical Trials.” Read here.
FDA restricts patient access to rosiglitazone
The U.S. Food and Drug Administration (FDA) has added new restrictions on how rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl): Healthcare providers must enroll in a…
FDA approves test to distinguish between MRSA and MSSA
The U.S. Food and Drug Administration (FDA) has cleared the first test that can quickly distinguish between methicillin resistant Staphylococcus aureus (MRSA) and methicillin…
FDA permits marketing of dengue fever test
The U.S. Food and Drug Administration is allowing marketing of the first test to help diagnose people with signs and symptoms of dengue fever.…
FDA warns companies to stop MRSA claims
The U.S. Food and Drug Administration has issued four warning letters to companies selling over-the-counter drug products, including hand sanitizers, telling them to stop…
Environment, health, & safety
With the growing reuse of single-use medical devices, ANA supports improvements in end-of-use product management and research on ethical and safety issues…
FDA updates safety data for silicone gel-filled breast implants
A new report of data from studies conducted by manufacturers confirms that silicone gel-filled breast implants are “safe and effective when used…
FDA proposes new policy for some devices
The U.S. Food and Drug Administration (FDA) has proposed a new policy that reduces premarket notification requirements related to devices that have…
FDA changes sunscreen labeling requirements
The U.S. Food and Drug Administration (FDA) has revised requirements for sunscreen labeling. The final rule takes effect by summer 2012. Read…
FDA releases draft guideline related to nanotechnology
The Food and Drug Administration (FDA) has released “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” a draft guidance document…
FDA approves Nulojix for prevention of acute rejection in kidney transplant patients
The U.S. Food and Drug Administration (FDA) has approved Nulojix (belatacept) for prevention of acute rejection in adult patients who have had…
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration (FDA) has approved the Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal total hip replacement system…
New FDA regulation for improving safety reporting in clinical trials discussed in The New England Journal of Medicine.
The June 8 edition of The New England Journal of Medicine includes “New FDA Regulation to Improve Safety Reporting in Clinical Trials.”…
FDA restricts patient access to rosiglitazone
The U.S. Food and Drug Administration (FDA) has added new restrictions on how rosiglitazone-containing medicines (Avandia, Avandamet, Avandaryl): Healthcare providers must enroll…
FDA approves test to distinguish between MRSA and MSSA
The U.S. Food and Drug Administration (FDA) has cleared the first test that can quickly distinguish between methicillin resistant Staphylococcus aureus (MRSA)…
FDA permits marketing of dengue fever test
The U.S. Food and Drug Administration is allowing marketing of the first test to help diagnose people with signs and symptoms of…
FDA warns companies to stop MRSA claims
The U.S. Food and Drug Administration has issued four warning letters to companies selling over-the-counter drug products, including hand sanitizers, telling them…
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