Clinical Research Solutions
US Opioid Epidemic: FDA Requests the Removal of Opioid from the Market
On Thursday, June 8th, the FDA requested that Endo Pharmaceuticals remove Opana® ER (oxymorphone hydrochloride), an opioid pain medication, from the market. History with FDA The FDA originally...
Clinical Research Solutions
FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings
On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...
Clinical Research Solutions
FDA Makes Changes to Regulations Concerning Humanitarian Use Devices
On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by...
Clinical Research Solutions
US Opioid Epidemic: NDA for Drug to Treat Opioid Use Disorder Submitted to FDA
On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...
Clinical Research Solutions
FDA Approves 1st Drug to Treat Cancer Based on Genetics of Tumor, Not Location
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....
Clinical Research Solutions
FDA Approves New Drug to Treat ALS
Anyone who was on social media in the summer of 2014 knows what the Ice Bucket Challenge was. Videos of people completing the challenge littered most people’s social media feeds, all in hopes of...
Clinical Research Solutions
NSAID Products Linked to Increased Risk of Heart Attack, Claim New Study Results
According to a recent study published in The BMJ, people who take nonsteroidal anti-inflammatory drugs may have a higher risk of suffering from myocardial infraction (i.e., a heart attack) than...
Clinical Research Solutions
FDA Approves New Drug for Advanced Bladder Cancer
On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...
Clinical Research Solutions
CREATES Act Reintroduced in House & Senate
On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees. The CREATES Act is a...
Clinical Research Solutions
FDA Approves First Drug for a Form of Batten Disease
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...