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.
News
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(FDA) has released “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” a draft guidance document available for…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 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 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 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…
FDA approves new treatment for metastatic melanoma
The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.
FDA approves contrast agent for CNS MRI scans
The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI) of the…
FDA approves new drug for COPD
The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary disease (COPD). Read more…
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 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 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 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…
FDA approves new treatment for metastatic melanoma
The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.
FDA approves contrast agent for CNS MRI scans
The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI)…
FDA approves new drug for COPD
The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary disease (COPD).…
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