HEALTH LAW SECTION BLOG
The Official Blog of the New York State Bar Association Health Law Section
Entries from HEALTH LAW SECTION BLOG tagged with 'drug safety'
2 Medications used to reduce risk of primary breast cancer
From AHRQ news Jan 14, 2010- New consumer and clinician summary guides on medications to reduce the risk of breast cancer in women are available from AHRQ’s Effective Health Care Program.The clinician guide summarizes the effectiveness and safety of two...
Posted by Joan Shipman on January 14, 2010 3:55 PM
FDA Basics aims to help consumers gain better understanding of agency
From FDA News Jan. 12 2010 (1) FDA unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process. During an online presentation, the chair of the...
Posted by Joan Shipman on January 14, 2010 3:50 PM
Pres. Obama's Weekly Address: 'Reversing a Troubling Trend in Food Safety' new FDA appointments
Pres. Obama's Weekly Address (3/14/09), excerpts from the Blog, White House transcript. The video can be viewed online at www.whitehouse.gov. 'In his weekly address, President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the FDA,...
Tags:
Posted by Joan Shipman on March 14, 2009 7:38 AM
FDA/WebMD collaboration; FDA Co Branding Policy- Consumer Health Info.
FDA and WebMD announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. WebMD, which attracts nearly 50 million unique visitors each month, provides consumers with credible and timely health news and information. (1)...
Tags:
Posted by Joan Shipman on December 3, 2008 10:39 AM
FDA Steering Committee/Expert Working Groups for ICH on Quality, Safety, Efficacy, Electronic Standards
International Conference on Harmonization (ICH) Public Meeting October 21, 2008, Rockville MD FDA announced a public meeting entitled “Preparation for ICH meetings in Brussels, Belgium” to provide information and receive comments on the ICH as well as the upcoming meetings...
Posted by Joan Shipman on September 28, 2008 8:21 AM
FDA's Quarterly Report: products and potential signals of serious risks/new safety information, AERS database.
Sept 5, 2008 FDA announced (1) that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.(2) The drugs have been identified based on a review of...
Tags:
Posted by Joan Shipman on September 6, 2008 4:33 PM
FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.
From CDER email news today: In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed...
Tags:
Posted by Joan Shipman on August 22, 2008 10:42 AM
GAO examines FDA oversight of promotion of drugs for off label uses
July 2008, US GAO published, 'Prescription Drugs FDA’s Oversight of the Promotion of Drugs for Off-Label Uses', a Report to the Honorable Charles E. Grassley, Ranking Member on Finance , US Senate. (29 pp + appendices) Drug companies provide medical...
Tags:
Posted by Joan Shipman on August 5, 2008 7:40 AM
A Trial in South Africa compares effectiveness of a primary care system on nurse-led ART
Published April 23, 2008 in "Trials" (1) an open access article shares a study protocol entitled: "Streamlining tasks and roles to expand treatment and care for HIV: [randomized] controlled trial protocol" Fairal, l, et al. The South Africa Free State...
Posted by Joan Shipman on April 24, 2008 7:01 AM
FDAAA-a 5 yr safety plan
Just out: FDA's "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan" draft document dated March 2008.(1) FDA will use this plan to communicate strategies FDA will follow for using PDUFA IV drug safety resources; communicate our current...
Tags:
Posted by Joan Shipman on April 2, 2008 8:42 AM
FDAAA of 2007 and "REMS"
From CDER's email news of today: FDA provides Q&A on the Federal Register Notice on Drugs and Biological Products Deemed to Have A Risk Evaluation and Mitigation Strategy ("REMS"). (1) [re: 3/27/08 Federal Register Notice see (2)] FDA is: identifying...
Posted by Joan Shipman on March 27, 2008 1:52 PM
FDA Amendments Act of 2007 Signed Into Law
The White House news reported Sept. 27, 2007 that "the President signed H.R. 3580, the FDA Amendments Act of 2007, which reauthorizes a number of Food and Drug programs including the PDUFA and MDUFA; extends and modifies authorities related to...
Tags:
Posted by Joan Shipman on September 28, 2007 7:51 AM
US House Passes Drug Safety Bill 403-16
On July 11, 2007 the United States House of Representatives passed H.R. 2900, the "FDA Amendments Act of 2007," by a vote of 403 to 16. It improves current drug safety provisions, encourages greater transparency and timeliness in the drug...
Posted by Joan Shipman on July 15, 2007 10:45 AM
Feed Subscription
If you use an RSS reader, you can subscribe to a feed of all future entries tagged 'drug safety'. [What is this?]
Other Tags
Other tags used on this blog:
- aca (1)
- ACA (1)
- access (5)
- accreditation standards (1)
- ACLU (3)
- ACO (2)
- admission agreement (1)
- adult homes (1)
- advanced therapy medicinal products (1)
- adverse events (8)
- adverse selection (1)
- advisory opinion (1)
- AERs (4)
- aetna (4)
- affordable care act (2)
- age discrimination (1)
- AHRQ (5)
- AIDS (1)
- alternative dispute resolution (1)
- AMA (3)
- ambulance (1)
- ambulatory surgery center (1)
- animals in research (2)
- anti-kickback (4)
- antitrust (2)
- applied gene therapy (1)
- assisted living facilites (2)
- ATMPs (1)
- attorney general (13)
- audit (9)
- authentication (1)
- autopsy (1)
- AWP (3)
- bankruptcy (4)
- behavioral science (1)
- benefit mandates (3)
- benefits (1)
- Berger commission (10)
- bioethics (3)
- biologics (1)
- biomarkers (4)
- biomedical informatics (1)
- biomedical technology (3)
- biometrics (1)
- biosafety (1)
- biosimilars (1)
- blogging (9)
- blood donors (2)
- blood screening tests (1)
- body tissues (1)
- botanical preparation (1)
- BPA (2)
- BRCA (4)
- breast cancer (1)
- brokers (2)
- Brookhaven (1)
- budget (11)
- cancer (8)
- carbon pollution (1)
- care management (1)
- CBER (2)
- CBO (2)
- CDC (1)
- CDER (6)
- CDPHP (1)
- CDT (2)
- cell therapy (2)
- CERHR (1)
- charitable purpose (1)
- child health plus (2)
- children (3)
- China (4)
- chronic care coordination (1)
- chronic disease (1)
- church and state (1)
- cigna (1)
- CIPIH (2)
- Citizen Media Law Project (1)
- claims (1)
- CLE (1)
- climate change (1)
- clinical laboratories (2)
- clinical practice (1)
- clinical trials (21)
- cloning (2)
- CMS (2)
- co-branding (1)
- COBRA (1)
- COI (2)
- collaboration (1)
- collective bargaining (1)
- combinatorial chemistry (1)
- Commonwealth Fund (1)
- comparative effectiveness (2)
- comparative law (1)
- competitiveness (1)
- compliance plans (1)
- compound authorizations (1)
- compound libraries (1)
- comptroller (1)
- CON (2)
- concierge medicine (1)
- conflicts of interest (3)
- conscience clause (1)
- Constitutional Law (1)
- construction (2)
- consumer (4)
- consumer health information (4)
- continuum (1)
- conversion (3)
- COPS (1)
- corporate practice of medicine (1)
- counterfeits (1)
- court administration and law (1)
- criminal charges (12)
- cuomo (14)
- cyber vocabulary (1)
- daines (2)
- data breach (7)
- data protection (4)
- database (5)
- DDMAC (1)
- death rates (1)
- diagnosis (1)
- dietary science and health relations (1)
- digital doctor-rural (1)
- digital technology (1)
- Dipnote (1)
- DNA (2)
- doctors across new york (2)
- DOH (17)
- domestic partner (3)
- donor eligibility/ testing (1)
- dose registry (1)
- downtown (1)
- drug development (4)
- drug discovery (4)
- drug disposal (1)
- drug labels (4)
- drug prescribing practices (2)
- drug price reports (1)
- drug product life cycles (1)
- drug production capability (1)
- drug promotions violations (1)
- drug risk evaluation and mitigation strategy (3)
- drug safety (13)
- Drug Safety Communication (1)
- drug shortage (1)
- drug side effects (2)
- drug/biologics products safety (1)
- e-health (3)
- e-prescribing (2)
- EIN (1)
- electronic health records (12)
- electronic medical records (16)
- emergency care (4)
- emergency department (4)
- empire (2)
- employer identification numbers (1)
- EMR (5)
- EMS (1)
- energy (1)
- environmental health (3)
- EPA (1)
- EPHT (1)
- epidemiology (1)
- epigenetics (1)
- ERISA (2)
- errors (3)
- ESSCB (8)
- ESSCB Ethics Committee (2)
- ethics (12)
- ethnobotanical preparation (1)
- EU's EMA (2)
- Europe (2)
- European Food Safety Authority (1)
- evidence-based medicine (3)
- exclusion (2)
- executive compensation (1)
- exempt organizations (5)
- expansion (2)
- external appeal (1)
- extrapolation (1)
- false claims (6)
- family health care decisions act (3)
- family law (1)
- family planning (4)
- FDA (19)
- FDA employees/MAPP (1)
- FDA risk/benefit communications (1)
- FDA Science board (1)
- FDA's quality by design (1)
- FDA's weekly issues column (1)
- FDAAA (11)
- federal civil litigation (1)
- fertility (2)
- FHCDA (3)
- fines (7)
- First Amendment (1)
- food safety (4)
- food stamps (1)
- food/diet-related diseases (1)
- foundations (1)
- fraud (33)
- FTC (3)
- full disclosure/caveat emptor (1)
- fundraising (1)
- gamete donation (2)
- GAO (1)
- gene patents (2)
- gene therapy (4)
- generally accepted professional practices (1)
- generics (1)
- genetic information (6)
- genetic terms glossary (1)
- genetic testing (6)
- genomic medicine (5)
- genomic research (1)
- Geron's regenerative product pipeline (1)
- GFP (1)
- GHI/HIP (4)
- global academic-industry collaboration (1)
- global health (8)
- global publications benchmarking (1)
- globalized economy (1)
- GLP (1)
- GME (3)
- GMP (1)
- Good Clinical Practice (1)
- google (2)
- grant (6)
- H1N1 (6)
- HANYS (2)
- HCAHPS (1)
- HCFAC (1)
- HCLD (1)
- HCRA (2)
- HEAL grants (2)
- health care costs (6)
- health care disparities (2)
- health care interventions (1)
- health care reform (30)
- health home (1)
- Health Indicators Warehouse (1)
- health information (4)
- health information exchange (2)
- health insurance (11)
- health IT (2)
- health maintenance organizations (2)
- health product development (1)
- health research science (1)
- Health Research Science Board (1)
- health research services (2)
- health researchers (1)
- health sciences (1)
- health services research (2)
- healthcare and life sciences (1)
- HealthNet (1)
- healthnow (2)
- healthy ny (2)
- HESC (5)
- HHC (3)
- high throughput screening (1)
- HIPAA (26)
- HIPAA security (2)
- HITECH (1)
- HIV (2)
- HMOs (2)
- home health (5)
- hospital closings (25)
- hospital-patient relationship (1)
- hospitals (68)
- HSCI (1)
- human blood transfusions (1)
- human genome research (1)
- human rights (1)
- human subject protection (6)
- hypertension (1)
- I-STOP (1)
- Iceland (1)
- ICH (4)
- improved medical treatments (1)
- incident reporting (1)
- indictment (1)
- individual mandate (1)
- individualized medicine (1)
- infection (2)
- infection rates (2)
- infectious diseases (1)
- influenza (1)
- information security (9)
- information technology (18)
- informed consent (8)
- ingenix (6)
- innovation ecosystem (1)
- innovation for health outcomes (1)
- innovation life sciences (9)
- innovative medical technologies (1)
- Inspector general (3)
- insurance (7)
- insurance department (27)
- int'l FDA pilot programs (1)
- international DNA banks (1)
- international genetic laws (1)
- international harmonization (4)
- international harmonization: pharma regs (2)
- international health affairs (4)
- international health policy perspectives (7)
- international law (3)
- international pharma industry (1)
- international research standards (3)
- international scientific collaboration (5)
- Internet freedom (1)
- internet pharmacy (1)
- Internet speech (1)
- IOM (1)
- IP (1)
- iPS cells (2)
- iPS Center NIH (1)
- IRB (2)
- IRBs (1)
- IRS (5)
- iSCNT (1)
- ISSCR (2)
- Japan (2)
- joint commission (1)
- jonathan's law (1)
- judiciary (1)
- kendra's law (1)
- law blog ideas (8)
- law blog related (3)
- law blogging (3)
- laws (3)
- leapfrog group (2)
- legal practice (2)
- legal profession (2)
- legal resources (6)
- legal service business resources (1)
- legislation (8)
- life sciences (2)
- long term care (1)
- malpractice (5)
- mammograms (1)
- managed care (9)
- mandates (2)
- marijuana (2)
- Markle Connecting for Health (1)
- massachusetts (11)
- maternity (2)
- MDUFMA (2)
- mediation (1)
- medicaid (45)
- medicaid recovery audit program (1)
- medical diagnostics (1)
- medical error (1)
- medical home (3)
- medical imaging safety (1)
- medical information (1)
- medical liability reforms (1)
- medical malpractice (1)
- medical records (3)
- medical research (4)
- medical science (1)
- medically necessary drug products shortages (1)
- medicare (18)
- medicare advantage (1)
- Medication Guides (1)
- MediSys (1)
- meetings (2)
- Memorial Sloan-Kettering Cancer Center (2)
- mental health (10)
- mercy medical center (1)
- mergers (7)
- MFCU (2)
- michelle's law (1)
- microsoft (2)
- midwifery (1)
- molecular tests (1)
- montefiore (1)
- mount sinai (1)
- MSSNY (1)
- Myriad gene patents (1)
- nanobioscience (1)
- nanobusiness (1)
- nanotechnology (2)
- National Academies (1)
- National Health and Nutrition Survey (1)
- National Organ Transplantation Act (1)
- natural products in chemistry (1)
- natural/unatural in biology (1)
- NCI (1)
- NCRP (1)
- NCVIA (1)
- near-misses (1)
- never events (2)
- new therapies (1)
- New York medical research institutions (5)
- new york-presbyterian (2)
- newborn screening program (1)
- NHGRI (1)
- Nigeria (1)
- NIH Challenge Grants in Health and Science Research (1)
- NIH NCATS (1)
- NIH NHGRI (1)
- NIH OTT model agreements (1)
- NIH stem cell research (1)
- NIH's CTSA (1)
- NIH's Feedback blog (1)
- non-network care (1)
- nonclinical abuse liability (1)
- nonclinical safety/efficacy studies (1)
- not HIPAA (1)
- not-for-profit (7)
- notice (2)
- nursing (9)
- nursing homes (11)
- nutrition (3)
- NYeC (1)
- NYHISPC (1)
- NYLJ health article (11)
- NYS ESD (1)
- NYSBA blogs (1)
- NYSTEM (20)
- obesity (2)
- observation units (1)
- off-label drug uses (2)
- Office of Health Information Technology Transformation (1)
- OHITT (1)
- OHRP (2)
- OIG (8)
- OMH (1)
- OMIG (9)
- on-line collaboration (1)
- on-line medical records (1)
- on-line purchase of medicine (1)
- oocyte donation risks (1)
- OPASI (1)
- organ donation (2)
- organ donors (1)
- organ procurement (3)
- organ procurement organization (1)
- organ transplants-financial incentives (1)
- orphan drugs (1)
- orszag (1)
- out-of-network care (5)
- outpatient clinic (1)
- overpayment (4)
- oversight (2)
- overtime (1)
- P2P (1)
- P4P (1)
- pandemic (1)
- paradigm shift (T. Kuhn) (1)
- paradigms (1)
- Parkinson's disease (1)
- partnership for coverage (4)
- patent case pilot project (1)
- paterson (5)
- patient abuse (1)
- patient de-identified data (1)
- patient informed consent (1)
- patient medical imaging card (1)
- patient rights (2)
- patient safety (2)
- pay-for-performance (3)
- payment (2)
- payors (1)
- PCMH (3)
- PDUFA (2)
- pediatric population studies (1)
- pediatric research (1)
- peer review (7)
- personal health record (4)
- Personal Health Records (1)
- personalized medicine (7)
- personalized treatment (1)
- personally identifiable data (1)
- pharmacogenomics (1)
- pharmacy (6)
- PHI (1)
- PHR (2)
- PHRs (2)
- physician self-referral (7)
- physician shortage (4)
- placebos (1)
- pluripotent stem cells (1)
- policy (1)
- policy and law (1)
- policy ideas (4)
- policy settings (1)
- post approval study (1)
- postmarketing drug safety (1)
- postmarketing risk surveillance (1)
- poverty (2)
- PPACA (3)
- pre-market approval (1)
- preemption (1)
- preet bharara (1)
- presciption drugs (3)
- prescription (2)
- prescription drugs (14)
- Presidential Proclamation (1)
- pressure ulcer (1)
- preventive care (1)
- primary care (5)
- principles-based regulation (1)
- prior approval (1)
- privacy (27)
- prompt pay (3)
- property taxes (1)
- protein mapping (1)
- proton beam therapy (1)
- psychoactive drugs (1)
- public access (1)
- public health (3)
- public health council (2)
- public health surveillance (5)
- public private partnerships (9)
- public-private collaborative (1)
- PUBPAT (3)
- punitive damages (1)
- qarr (2)
- quality (15)
- quality assurance (1)
- R&D (2)
- rankings (13)
- rare diseases (1)
- ratios (1)
- rDNA research activity (1)
- readmissions (1)
- Reagan-Udall (1)
- records (1)
- recoupment (2)
- Redbook 2000 (1)
- redi-clinics (6)
- reform (14)
- regenerative medicine (7)
- regulations (8)
- regulatory processes (1)
- Regulatory Science Program NIH (1)
- reimbursement (5)
- religious employers (2)
- REMs (1)
- REMS (2)
- reporting (1)
- reports (1)
- reproduction toxicity studies (1)
- reproductive biology (1)
- research (2)
- research board governance (3)
- research consortium (1)
- research output (1)
- research resources (4)
- research subjects (1)
- results-oriented regulatory processes (1)
- retail clinics (7)
- reviews (2)
- RHIO (4)
- risk/benefit assessment research (1)
- rural physicians (1)
- Safe Use Initiative (1)
- SCHIP (1)
- science and statistics in law (1)
- science in law (13)
- science/philosophy (2)
- scientific integrity (6)
- SCNT (1)
- screening (4)
- security breach (2)
- serbaroli (16)
- shared savings (1)
- sheehan (2)
- simulated human browsing (1)
- single payer (2)
- spinal cord injury (1)
- spitzer (6)
- st. francis (1)
- st. vincent's (12)
- standardized measures (2)
- standards (6)
- standarized measures (1)
- stark (7)
- state initiatives (5)
- stem cells (35)
- subpoenas (1)
- subsidies (1)
- substance use disorder (1)
- Supreme Court (7)
- surcharges (1)
- swidler (1)
- synthetic biology (1)
- taxes (6)
- technology transfer (1)
- telemedicine (1)
- therapeutic cloning techniques (1)
- therapeutic development (1)
- tissue (2)
- tissue banking (1)
- torts (1)
- toxic chemical exposure (1)
- toxicology (1)
- transparency (15)
- twitter (1)
- UCR (2)
- UIDP (1)
- UK (2)
- uninsured (7)
- unions (6)
- unitedhealth (2)
- universal coverage (13)
- UNOS (1)
- upstate (3)
- US-China PPP (1)
- USITC global healthcare services biotech SMEs (1)
- usual and customary (6)
- vaccines (13)
- virus (1)
- wal-mart (1)
- Web of Science (1)
- web scraping (1)
- webcast (1)
- wellcare (1)
- wellness (2)
- wellpoint (1)
- whistleblower (1)
- World Health Assembly (1)
- young lawyers (1)