Thursday, April 2, 2020

Thursday, April 2, 2020

Latest News

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality.

U.S. FOOD AND DRUG ADMINISTRATION: The Least Burdensome Provisions: Concept and Principles Final Guidance - March 14, 2019

On Thursday, March 14, 2019, the FDA will host a webinar on the final guidance entitled, "The Least Burdensome Provisions: Concept and Principles."

U.S. FOOD AND DRUG ADMINISTRATION: Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019

On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.”

U.S. FOOD AND DRUG ADMINISTRATION: Public Workshop - Forum on Laser-Based Imaging - April 8, 2019

The Forum will focus on the latest trends and enhancements in laser-based imaging modalities such as Optical Coherence Tomography (OCT) and Adaptive Optics (AO), regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tool Program and the emerging role of Artificial Intelligence.

U.S. FOOD AND DRUG ADMINISTRATION: State of CDER 2019

An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research

U.S. FOOD AND DRUG ADMINISTRATION: Drug Shortages

Drug shortages have a significant impact on both hospitals and patients.

U.S. FOOD AND DRUG ADMINISTRATION: The Breakthrough Therapy Designation

For two decades, CDER has used certain methods to speed drug development and the regulatory review process so that promising therapies can get to patients faster.

FDA issues safety alert regarding wearable defibrillator; two deaths attributed to software defect

Safety concerns have led to a government warning about a wearable defibrillator.

FDA issues warning of possible medical device shortage following shutdown of Sterigenics plant

FDA is warning of the possibility of a shortage of sterilized medical devices, possibly posing a threat to public health.

U.S. FOOD AND DRUG ADMINISTRATION: USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause heart failure symptoms such as shortness of breath, fatigue and swelling in the legs.

U.S. FOOD AND DRUG ADMINISTRATION: FDA allows marketing of new device to help treat carbon monoxide poisoning

The U.S. Food and Drug Administration allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning.

FDA finds 32,000 malfunctions, 366 deaths involving surgical staples over seven years

The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally.

Gottlieb weighs in on naming scheme for biological medicines for competition and patient safety

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement last week on the importance of naming biological medicines that will benefit by having a lower cost to patients.

PHARMACEUTICS INTERNATIONAL, INC.: Pii to Manufacture FDA-approved Busulfan Injection Drug Product

Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.

ALLERGAN, PLC: Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.: Announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD

Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.

FDA Health News