general regulatory

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...

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...

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...

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...

FDA Warns 14 Companies for Illegally Selling Fake Drugs Claiming to Cure Cancer

On Tuesday, April 25th, the FDA released warning letters that were recently issued to 14 US-based companies. These warning letters were issued with regards to the illegal sale of products that claim...

FDA Approves 5th Biosimilar Product

On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....

FDA Mandates Texas & Arizona to Destroy or Export Lethal Injection Drugs

On Thursday, April 20th, the FDA formally ordered both Texas and Arizona to refuse and either destroy or export all execution drugs within 90 days. Background Texas was the first state to begin...

FDA Changes Labeling Requirements to Protect Children from Pain & Cough Medicines

On Thursday, April 20th, the FDA issued a statement announcing a number of changes that are being made to the labeling requirements for two opioids – codeine and tramadol. The Agency’s statement...

Congress Drafts Bill to Extend the User Fee Programs

On Friday, April 14th, a draft bill was released, aimed at reauthorizing the user fee programs for branded and generic drugs, medical devices, and biosimilar products. Committees from the House of...

FDA Announces Recall of EpiPen & EpiPen Jr.

On Friday, March 31st, the FDA informed consumers of “Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products.” These...

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