FDAnews Drug Daily Bulletin

The New England Compounding Center (NECC), at the heart of a nationwide fungal meningitis outbreak, dropped the ball after seeing early signs of unacceptable levels of microbial contamination, the FDA says.

Mexican drug regulator Cofepris has doubled its clinical trial protocol review timeline, with approvals coming in six months now instead of three, an expert says.

Amgen and Novartis want the FDA to clarify which compounds would require an assessment of suicidal thoughts and behaviors under draft guidance the agency issued in August.

After gaining market access under a contingency plan by the FDA, drug major Sun Pharmaceutical Industries is awaiting approval from the health regulator for its cancer drug Lipodox.

Over the past 18 months, 81-year-old Bill Bunnell has visited the doctor a half-dozen times to take memory tests, provide blood samples and undergo a spinal tap and imaging scans.

Pfizer is laying off 300 professionals or 11 percent of its Canadian workforce as the drug multinational reduces its costs to soothe the revenue erosion from expired patents such as its blockbuster cholesterol-lowering drug Lipitor.

The Florida Department of Health Friday issued an Emergency Suspension Order against Rejuvi Pharmaceuticals.

Par Pharmaceutical announced that its operating subsidiary, Anchen Pharmaceuticals, has received final approval from the FDA for its ANDA for tretinoin capsules, 10 mg.

Those in the habit of pill-popping had better stock up.