This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles.
,,TM56dzCfq-Q,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_TM56dzCfq-Q,On September 18th and 19th 2025, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop presented a draft version of an updated evidence dossier template to facilitate the submissions of evidence to FDA to support a Clinical Outcome Assessment.
,,DwXNIDqpdOM,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_DwXNIDqpdOM,On September 18th and 19th 2025, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop presented a draft version of an updated evidence dossier template to facilitate the submissions of evidence to FDA to support a Clinical Outcome Assessment.
,,wns7dVIW4V4,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_wns7dVIW4V4,On September 24, 2025, the Food and Drug Administration (FDA) held a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment," to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). This assessment built upon the findings from three previous assessments conducted by independent contractors under previous PDUFA and BsUFA reauthorizations.
For more background information on the meeting, please see the Federal Register Notice with assigned docket FDA-2025-N-2962.
https://www.federalregister.gov/documents/2025/08/25/2025-16245/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment
To provide a public comment, please visit the public docket. The public docket closes on October 24, 2025. https://www.regulations.gov/document/FDA-2025-N-2962-0001
,FDA,CDER,SBIA,Regulatory,Education,Industry,REdI,Clinical,Trial,Compliance Approaches,Emerging Threats,Pharmaceutical Inspection,Compliance Data,Bioresearch Monitoring,BIMO,Drug Supply Chain,Recalls,Compounded Drugs,Drug Registration and Listing,Oversight,Compliance,Warning Letters,Closing,QWIX857Shsk,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_QWIX857Shsk,The closing remarks to wrap up the Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development.
Timestamps
01:08 – Oversight Responsibilities
02:18 - Mission
02:33 – Compliance Tools and Activities
05:53 – Risk-Based Compliance Actions
06:39 – Safeguarding the Drug Supply Chain
12:09 – Remote Tools
17:24 – Ophthalmic Products
22:08 – Unapproved Drugs
24:45 – Warning Letters Issued
26:08 – Outreach and Communication
28:09 – Pharmaceutical Inspections and Compliance
31:12 – FDA Data Dashboard
33:34 – Unified Compliance
35:50 – Summary
Speaker:
Jill P. Furman, JD
Director
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
,1,When should the US use its military power and who should it sell/give weapons to? There are no easy answers. In 2011 it seemed as though the international military force was justified to prevent Muammar Gaddafi from slaughtering the people of Benghazi. Sam admits he supported the US using its military in that instance but now looks back with reservations. Now the US is funneling billions of dollars in aid and weapons systems to Ukraine. It may seem like the right thing to do now but what happens to those weapons when the conflict ends?
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,,gQhRTWQ1q_8,, Health,Knowledge, channel_UC_giJ3xlEL9jUF1YfJdzzuQ, video_gQhRTWQ1q_8,This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles.
,physiology,nursing,NCLEX,health,disease,biology,medicine,nurse education,medical education,pathophysiology,campbell,human biology,human body,qhT0lQ7X9d8,, Health, channel_UCF9IOB2TExg3QIBupFtBDxg, video_qhT0lQ7X9d8,Isle of Wight mushroom farm, https://www.iwmushrooms.co.uk/
Lions main, Hericium erinaceus
Long history of usage in traditional Chinese medicine
https://www.mdpi.com/2072-6643/17/8/1307
https://pubmed.ncbi.nlm.nih.gov/34169530/
Lots of bioactive compounds, polysaccharides (notably β-glucans), terpenoids, phenolic compounds, polyphenols, and peptides, bioactive proteins
Diverse health-promoting properties.
Functional food / mushroom, nutraceutical
Safer and more sustainable health solutions
Nutritional perspective
Mushrooms, proteins, fibre, vitamins (B1, B2, B3, B5, B6 and D precursors), selenium, zinc, and potassium
Low-calorie: high nutrient density ratio
Prebiotic fibers, gut health, growth of beneficial microbiota, contributing to improved digestion and immune function
Peripheral neuronal regeneration
https://pubmed.ncbi.nlm.nih.gov/23510212/
Functional recovery following crush injury to the peroneal nerve in rats
Stimulated regrowth of motor endplates/neuromuscular junction
More rapid improvement in motor function
PNS mechanisms
Activation of genes in dorsal root ganglia neurons (cell bodies of sensory neurones)
Activates genes to produce neurotrophins
Neurotrophic factors, Nerve Growth Factor
These promote cell survival and stimulate nerve fibre growth
Promote protein synthesis in damaged neurones
Central nervous system maintenance and regeneration
Preventing and managing neurodegenerative diseases
Preclinical studies, improvements in ischemic stroke, Parkinson's disease, Alzheimer's disease,
Depression and anxiety
Enhancing cognitive function
https://restorativemedicine.org/wp-content/uploads/2017/12/lions-mane.pdf
CNS mechanisms
Can cross the blood brain barrier
https://verybigbrain.com/nootropics/brain-cell-regeneration-the-remarkable-effects-of-lions-mane-mushroom/
Neurotrophic factors, Brain Derived Neurotrophic Factor, Nerve Growth Factor
AD and PD, where oxidative stress plays a central role
Scavenging reactive oxygen species and inducing endogenous antioxidant enzymes such as superoxide dismutase (SOD)
Terpenoids
Hericenones, A to L
Fruiting body
Stimulates NGR, and mimics NGF (mimetic)
Cognitive enhancement and memory improvement
Increases nerve cell growth, fibre formation, new connection formation in hippocampus
Erinacenes, A to Z2
Mycelium
Erinacine A, shown to increase nerve growth factor (NGF) levels in the brain, promoting neurogenesis and neuronal survival
Stimulates NGF and is a brain anti-inflammatory
Reducing neuroinflammation and systemic inflammation
Suppressing glial cell inflammatory activation
(Excessive microglial activation is a known problem in AD,
oxidative stress accelerates neuronal damage)
Potent neuroprotective effects
Anti-inflammatory, antioxidant, immunological effects
Chronic inflammation and oxidative stress are underlying factors in a wide range of diseases,
Including cardiovascular disorders, diabetes, neurodegenerative illnesses, and cancer
Conventional treatments rely on synthetic drugs, significant side effects and long-term health risks
Neutralize ROS and reduce oxidative stress in neuronal cells
Downregulate pro-inflammatory cytokines (IL-6, TNF-α, IL-1β),
while upregulating anti-inflammatory cytokines.
Reduced prostaglandin synthesis (COX 2 inhibitor)
Immunomodulatory
Restoring gut microbiota, reducing systemic inflammation
Extract significantly increased SOD, CAT, and GPx levels, protecting liver cells from oxidative damage
Antimicrobial activities
Antibiotic effect
Inhibiting bacterial protein synthesis
Bacteriostatic
Bactericidal
Rise in antibiotic-resistant pathogens, overuse, disuse, MRSA, MDRTB - significant threat to public health
Several studies suggest that its bioactive compounds may act synergistically with conventional antibiotics, improving antimicrobial activity
All extracts displayed antibacterial activity against both Gram-positive and Gram-negative bacteria, novel mechanisms of action,
Potential applications in combating antibiotic-resistant infections.
Active against MRSA
Antibiotic mechanisms
Prevents biofilm formation
Phenolic compounds, have been shown to interfere with bacterial and fungal cell membranes
Gram-positive bacteria, which have a thick peptidoglycan layer that is more susceptible to membrane-targeting agents
Inhibit key bacterial enzymes involved in cell wall synthesis, DNA replication, and energy metabolism
Safety of lions mane use
Generally recognized as safe (GRAS)
Allergies
Anticoagulants, antiplatelet
Idiosyncratic interactions possible but unlikely
