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.
An audio podcast series featuring the Director of FDA Center for Drug Evaluation and Research
Drug shortages have a significant impact on both hospitals and patients.
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.
Safety concerns have led to a government warning about a wearable defibrillator.
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.
The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally.
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), 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.
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.
Viome, a company transforming health through personalized nutrition based on individual biology, today announces it will collaborate with precision health leader, Helomics, to study the link between the gut microbiome and ovarian cancer.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the Food and Drug Administration.
Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today issued a statement on Biogen Inc.'s decision to discontinue its global Phase 3 trials of aducanunab in Alzheimer's disease.
The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.
U.S. FOOD AND DRUG ADMINISTRATION: FDA Accepts the Citizen Petition by Prof. Niazi, to Withdraw the Naming Guidance for Biosimilars
The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform