Argentina - Drug Information Association

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Language: English USA - Public Comment/Docket No. FDA-2010-D-0319: Plasma Protein Therapeutics Association (PPTA), 11-Jan-2011 This document contains the public comments from the Plasma Protein Therapeutics Association (PPTA) on the FDA Draft Guidance: "Dear Health Care Provider Letters: Improving Communication of Important Safety Information" (115856). FDA announced the availability of this guidance in the Federal Register on November 12, 2010 (Volume 75, Number 218) (115854). This guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products and provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. Document date: 18-Jan-2011 Type of text: Public Comment Regulatory version: None Language: English USA - Public Comment/Docket No. FDA-2010-D-0319: Sanofi-Aventis U.S. Inc, 11-Jan-2011 This document contains the public comments from Sanofi-Aventis U.S. Inc, on the FDA Draft Guidance: "Dear Health Care Provider Letters: Improving Communication of Important Safety Information" (115856). FDA announced the availability of this guidance in the Federal Register on November 12, 2010 (Volume 75, Number 218) (115854). This guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products and provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. Document date: 18-Jan-2011 Type of text: Public Comment Regulatory version: None Language: English USA - Public Comment/Docket No. FDA-2010-D-0319: Sunovion Pharmaceuticals Inc., 07-Jan-2011 This document contains the public comments from Sunovion Pharmaceuticals Inc., on the FDA Draft Guidance: "Dear Health Care Provider Letters: Improving Communication of Important Safety Information" (115856). FDA announced the availability of this guidance in the Federal Register on November 12, 2010 (Volume 75, Number 218) (115854). This guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products and provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. Document date: 18-Jan-2011 Type of text: Public Comment Regulatory version: None Language: English USA - Impact Report: Comparative Effectiveness Research Impacts Patient Access to Cancer Drugs: Tufts CSDD Study Compares Access to Cancer Drugs in the US & Australia, Jul-2010 Main points in this July/August 2010 report are: - Oncology drug approvals in the U.S. outpaced Australian approvals by more than 60%. - Regulatory approval in Australia does not necessarily lead to reimbursement, as the threshold for reimbursement is higher, i.e., it is based on comparative effectiveness evidence. - Australia imposes greater restrictions than the U.S. on reimbursement of oncology drugs. - Patient cost sharing is significantly lower in Australia than the U.S. - Oncology drug prices in Australia average 30% less than in the U.S., due in part to value-based pricing, which is linked to comparative effectiveness research. - Australia, the first country to adopt a formal set of regulatory procedures to make coverage decisions based partly on cost-effectiveness, has been emulated by others. Document date: Jul-2010 Type of text: Publication, Report Regulatory version: None Language: English USA - Outlook Report 2011, Jan-2011 This TUFTS 2011 Outlook Report presents the progress and the development trends in the fields of R&D efficiency, regulatory environment, biotechnology trends, prescription drug policy and drug development management trends. It also contains research milestones projects due for completion and a glossary.
Document date: Jan-2011 Type of text: Publication, Report Regulatory version: None Language: English USA - Oncologic Drugs Advisory Committee (Draft Roster): Updates on the Status of Phase 4 Clinical Studies for NDAs & BLAs Approved Under 21 CFR 314.500 & 601.40 Prior to January 1, 2009 for: ERBITUX (cetuximab), BEXXAR (tositumomab/iodine I 131 tositumomab), CLOLAR (clofarabine), ARRANON (nelarabine), VECTIBIX (panitumumab) & GLEEVEC (imatinib mesylate), 08-Feb- 2011 On February 08, 2011, the Oncologic Drugs Advisory Committee members will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are postmarketing studies to confirm clinical benefit of a drug after it receives accelerated approval. Specifically, the committee will receive updates on the following products: (1) BLA 125084, trade name ERBITUX (cetuximab), application submitted by Imclone Systems Inc., used in combination with the anticancer agent irinotecan and indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond the colon or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR (tositumomab and Iodine I 131 tositumomab), application submitted by SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, indicated for the treatment of patients with varieties of non-Hodgkin’s lymphoma known as CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin’s lymphoma, who have not received the drug Rituximab; (3) NDA 21–673, tradename CLOLAR (clofarabine) for intravenous infusion, application submitted by Genzyme Corp., indicated for the treatment of pediatric patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) whose disease has not responded to or has relapsed following treatment with at least two prior chemotherapy regimens; (4) NDA 21–877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or lymphoma known as T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens; (5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted by Amgen Inc., indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens; and (6) sNDA 21–588/025, tradename GLEEVEC (imatinib mesylate) tablets, application submitted by Novartis Pharmaceuticals Corp., indicated for the adjuvant (additional) treatment of adult patients following complete gross resection (removal) of a form of cancer known as Kit (CD117) positive gastrointestinal stromal tumors (GIST). Based on the updates provided, the committee will have a general discussion centering on possible ways to improve the planning and conduct of trials to confirm clinical ... Document date: 08-Feb-2011 Type of text: Roster Regulatory version: None Language: English USA - Arthritis Advisory Committee (Slides / Handouts): Biologic License Application (BLA) 125370: BENLYSTA (Belimumab), Human Genome Sciences, for Reducing Disease Activity in Adult Patients with Active, Autoantibody- Positive Systemic Lupus Erythematosus, 16-Nov-2010 The Arthritis Advisory Committee (104455) (AAC) agreed in the majority that the data presented for Benlysta (belimumab), from Human Genome Sciences, Inc, are sufficient to support approval of the agent. Benlysta is an investigational agent proposed to reduce disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE), in combination with standard therapy. The suitable efficacy results and supportable safety findings were the key drivers of the vote. Document date: 16-Nov-2010 Type of text: Slides Regulatory version: None Language: English USA - Peripheral & Central Nervous System Drugs Advisory Committee (Slides / Handouts): Day 1: New Drug Application (NDA) 202-008: AMYVID (Florbetapir F 18 Injection), Avid Radiopharmaceuticals, Inc, for Use in Positron Emission Tomography (PET) Imaging of β-Amyloid (Beta-Amyloid) Aggregates in the
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Argentina - Drug Information Association

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