FDA – Page 12 – media

Drug Safety Communication – Boxed Warning Added To Highlight Correct Dosing

FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.
- Source: fda
- 568
- February 6, 2018
Boxed Warning FDA liver disease Ocaliva PBC
Ferring’s ZOMACTON® (somatropin) for Injection Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

Administration (FDA) has approved ZOMACTON® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
- Source: medindia.net
- 626
- February 5, 2018
FDA GH deficiency growth hormone ZOMACTON®
FDA Clears UC Davis Startup’s Polymer to Aid Bone Regrowth

Molecular Matrix Inc. invented a synthetic bone void filler, Osteo-P, that can help injured bones regrow.
- Source: ODT
- 605
- February 1, 2018
bone FDA medical device
Enzychem Lifesciences Announces the FDA Orphan Drug Designation Granted to EC-18 on Acute Radiation Syndrome (ARS)

Enzychem Lifesciences, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS).
- Source: china-pharmacy
- 597
- February 1, 2018
ARS EC-18 FDA Orphan Drug Designation rare diseases
FDA steps up efforts at bringing about medical device cyber security

It is a disturbing, but true fact that medical devices are hacked. Medical devices have inbuilt software, and hackers try to breach this. Medical device cybersecurity is thus critical, because lack of it can bring harm to patients who use medical devices that come with software built into them.
- Source: COMPLIANCE4ALL14
- 638
- January 31, 2018
cybersecurity FDA medical device Policy
Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
- Source: Novartis
- 491
- January 29, 2018
FDA GEP-NETs Lutathera® New Approvals
Cybersecurity for Medical Device Endpoints

With the recent, highly publicized incidents of identity theft, ransomware and malware attacks directed at healthcare facilities, the medical device community is on high-security alert.
- Source: WIBU Systems
- 793
- January 29, 2018
cybersecurity FDA Market Views medical device
FDA to expedite release of recall information

When the FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public hazards, including those recalls associated with an outbreak.
- Source: Mass Device
- 651
- January 22, 2018
Consumer Healthcare FDA Policy
3D Printing Goes Legit with FDA Guidance

The FDA guidance does give potential 3D medical device manufacturers a path to follow to prepare for FDA approval.
- Source: HealthTech Insider
- 620
- January 18, 2018
3D printing FDA medical device products Policy
Afatinib Approval Expanded for Rare Lung Cancer Treatment

Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
- Source: Raredr
- 710
- January 17, 2018
afatinib DNA FDA New Approvals NSCLC

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