USFDA CBER - Annual Summary for Fiscal Year 2014

Center for Biologic Evaluation and Research at USFDA has released its Annnual Summary Report for the Fiscal Year 2014.
FDA requires reporting of certain deviations and unexpected events in manufacturing in
accordance with 21 CFR 600.14, 606.171 or 1271.350(b). 
Manufacturers of licensed biological products other than blood and blood components (licensed non-blood) who hold the biological product license for and had control over the product when a deviation or unexpected event occurred are required to submit Biological Product Deviation (BPD) reports (21 CFR 600.14)
tothe Center for Biologics Evaluation and Research (CBER), if the safety, purity, or potency of a distributed product may be affected. Licensed manufacturers of blood and blood components,including Source Plasma; unlicensed registered blood establishments; and transfusion serviceswho had control over the product when a deviation or unexpected event occurred are alsorequired to submit BPD reports (21 CFR 606.171), if the safety, purity, or potency of adistributed product may be affected. In addition, manufacturers of nonreproductive Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/P) regulated by FDA solely under section 361 of the Public Health Service Act and 21 CFR Part 1271 are required to submit deviation reports [21 CFR 1271.350(b)] involving distributed products, if the deviation or unexpected event is related to a
Core CurrentGood Tissue Practice requirement[21 CFR 1271.150(b)] and related to the prevention of communicable disease transmission or HCT/P contamination.
Detailed information concerning deviation reporting, including guidance documents on BPD reporting for blood and plasma establishments (Ref. 1) and licensed manufacturers of biological products other than blood and blood components (Ref. 2), is available CLICK HERE.
This annual summary report provides an overview of the reports we received during the fiscal year, including detailed information regarding the number and types of deviation reports received. 
We provide combined data received over the last three fiscal years in an effort to compare data and highlight changes.
Throughout the analysis, we report numbers from past reports, calculate changes, or consider aggregate counts from multiple BPD codes. These data may or may not be included in accompanying tables. 
Detailed counts for all BPD codes can be found in the attachments and past summary reports are available CLICK HERE
 

USFDA: New and Generic Drug Approvals: 30 MAR 2015

New and Generic Drug Approvals

March 30, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aceon perindopril erbumine Tablet;Oral Symplmed Pharms Llc Labeling Revision
Advil Congestion Relief ibuprofen; phenylephrine hydrochloride Tablet;Oral Pfizer Labeling Revision
Cesamet nabilone Capsule;Oral Meda Pharms Manufacturing Change or Addition
Choline C-11 choline c-11 Injectable;Intravenous Mcprf Manufacturing Change or Addition
Depakote Er divalproex sodium Tablet, Extended Release;Oral Abbvie Labeling Revision
Edecrin ethacrynic acid Tablet;Oral Aton Manufacturing Change or Addition
Estrostep 21 ethinyl estradiol; norethindrone acetate Tablet;Oral-21 Warner Chilcott Llc Manufacturing Change or Addition
Estrostep Fe ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Llc Manufacturing Change or Addition
Fanapt iloperidone Tablet;Oral Vanda Pharms Inc Manufacturing Change or Addition
Omeprazole omeprazole Tablet, Delayed Release;Oral Dexcel Pharma Manufacturing Change or Addition
Pancreaze pancrelipase (amylase;lipase;protease) Capsule, Delayed Release;Oral Janssen Pharms Manufacturing Change or Addition
Qudexy Xr topiramate Capsule, Extended Release;Oral Upsher Smith Efficacy Supplement with Clinical Data to Support
Rapamune sirolimus Tablet;Oral Pf Prism Cv Manufacturing Change or Addition
Retisert fluocinolone acetonide Implant;Intravitreal Bausch and Lomb Manufacturing Change or Addition
Salonpas menthol; methyl salicylate Patch;Topical Hisamitsu Pharm Co Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Solution;Irrigation B Braun Manufacturing Change or Addition
Solaraze diclofenac sodium Gel;Topical Fougera Pharms Manufacturing Change or Addition
Sterile Water In Plastic Container sterile water for irrigation Liquid;Irrigation B Braun Manufacturing Change or Addition
Topotecan Hydrochloride topotecan hydrochloride Solution;Intravenous Teva Pharms Usa Manufacturing Change or Addition
Urex methenamine hippurate Tablet;Oral Cnty Line Pharms Manufacturing Change or Addition
Zaroxolyn metolazone Tablet;Oral Ucb Inc Manufacturing Change or Addition

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. 
Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

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UK MHRA - Medical device alert

Hudson RCI© humidifier adaptors and Aquapak sterile water with humidifier adaptors - risk of inhaling plastic pieces
(Teleflex Medical) Some packages contain pieces of plastic that could get into the gas flow path and enter the lungs (MDA/2015/015).
For further information on this alert: 

USFDA CDRH - List of Medical Devices Cleared/Approved in the 2014...

The products listed in this section include some of the newest medical technology from the year 2014. 

The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. 

This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.


Medical Devices Cleared or Approved by FDA in 2014


Device NameCategoryDate
Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter - P140010 Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 12/30/14
Bellafill PMMA Collagen Dermal Filler - P020012/S009 Dermal filler 12/23/14
BRACAnalysis CDx - P140020 Ovarian Cancer 12/19/14
TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D) - P980040/S049 Artificial Lenses 12/17/14
Barostim neo Legacy System - H130007 Implantable Pulse Generator (IPG) 12/12/14
Animas Vibe System - P130007 Glucose Monitoring 11/25/14
IDEAL IMPLANT Saline-filled Breast Implant - P120011 Breast Implants 11/14/14
TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment - P130026 Catheter 10/24/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System - P120005/S018 Glucose Monitoring 10/21/14
EverFlex Self-Expanding Peripheral Stent System – P110023/S007 Stent 10/10/14
Lutonix 035 Drug Coated Balloon PTA Catheter - P130024 Angioplasty 10/09/14
XIENCE Family of Everolimus Eluting Coronary Stent Systems - P070015/S122 and P110019/S066 Stent 10/03/14
GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface - P040037/S060 Stent 09/19/14
SenoClaire - P130020 Mammography 08/26/14
Pleximmune - H130004 Blood Test 08/26/14
XPS System with STEEN Solution Perfusate - H120003 Lung Transplant 08/12/14
Cologuard - P130017 Stool Test 08/11/14
Low-Profile Visualized Intraluminal Support Device (LVIS and LVIS Jr.) - H130005 Stent 07/25/14
Prestige LP Cervical Disc - P090029 Cervical Disc 07/24/14
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) - P130030 Stent 06/27/14
Sorin Freedom SOLO Stentless Heart Valve and SOLO Smart Stentless Heart Valve - P130011 Stentless Heart Valve 06/24/14
Fluency Plus Endovascular Stent Graft - P130029 Endovascular Stent Graft 06/17/14
Edwards SAPIEN XT Transcatheter Heart Valve - P130009 Heart Valve 06/16/14
Restylane Silk Injectable Gel - P040024/S072 Injection 06/13/14
Medtronic CoreValve System - P130021/S002 Aortic Heart Valve 06/12/14
artus CMV RGQ MDx Kit - P130027 Cytomegalovirus (CMV) DNA Test 06/02/14
CardioMEMS HF System - P100045 Pulmonary Artery Pressure 05/28/14
therascreen KRAS RGQ PCR Kit - P110027 Automated Molecular Assay 05/23/14
ADVIA Centaur® HBsAgII - P110041 hepatitis B virus (HBV) 05/16/14
GEL-SYN - P110005 Osteoarthritis 05/09/14
Inspire Upper Airway Stimulation - P130008 Obstructive Sleep Apnea 04/30/14
cobas® HPV Test - P100020/S008 HPV Test 04/24/14
Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381 Pacemaker/Defibrillator 04/10/14
Supera Peripheral Stent System – P120020 Peripheral Stent 03/28/14
Nucleus® Hybrid™ L24 Cochlear Implant System – P130016 Cochlear Implant System 03/20/14
Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg - P130015 Hepatitis B Test 03/14/14
MONOVISC™ - P090031 Joints 02/25/14
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S002 Glucose Monitoring 02/03/14
Medtronic Valiant Thoracic Stent Graft with Captivia Delivery System - P100040/S012 Stent Graft 01/22/14
Medtronic CoreValve System - P130021 Artificial aortic valve 01/17/14
ReSure® Sealant - P130004 Surgical Sealant 01/08/14

USFDA : Guidance for Industry - Critical Path Innovation Meetings...

Today, the U.S. Food and Drug Administration released a draft guidance: “Procedures for Meetings of the Medical Devices Advisory Committee.”  

Advisory committees play an important role in the FDA’s regulation of medical devices by providing independent expert advice on complex scientific and technical matters.

This new draft guidance describes the general circumstances in which FDA’s Center for Devices and Radiological Health (CDRH) convenes a panel of the Medical Devices Advisory Committee. The guidance also discusses the process and timelines for the exchange of information between CDRH and the members of the panel, industry, and the public. 

USFDA: New and Generic Drug Approvals: 27 MAR 2015

New and Generic Drug Approvals

March 27, 2015


Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision
Aptivus tipranavir Capsule;Oral Boehringer Ingelheim Labeling Revision
Aptivus tipranavir Solution;Oral Boehringer Ingelheim Labeling Revision
Cordarone amiodarone hydrochloride Tablet;Oral Wyeth Pharms Inc Labeling Revision
Emsam selegiline Film, Extended Release;Transdermal Somerset Labeling Revision
Eovist gadoxetate disodium Solution;Intravenous Bayer Hlthcare Efficacy Supplement with Clinical Data to Support
Invirase saquinavir mesylate Capsule;Oral Hoffmann La Roche Labeling Revision
Invirase saquinavir mesylate Tablet;Oral Hoffman La Roche Labeling Revision
Kaletra lopinavir; ritonavir Capsule;Oral Abbvie Labeling Revision
Kaletra lopinavir; ritonavir Solution;Oral Abbvie Labeling Revision
Kaletra lopinavir; ritonavir Tablet;Oral Abbvie Labeling Revision
Lexiva fosamprenavir calcium Tablet;Oral Viiv Hlthcare Labeling Revision
Lexiva fosamprenavir calcium Suspension;Oral Viiv Hlthcare Labeling Revision
Mirapex pramipexole dihydrochloride Tablet;Oral Boehringer Ingelheim Labeling Revision
Mirapex Er pramipexole dihydrochloride Tablet, Extended Release;Oral Boehringer Ingelheim Labeling Revision
Norvir ritonavir Capsule;Oral Abbvie Labeling Revision
Prezista darunavir ethanolate Tablet;Oral Janssen Prods Labeling Revision
Prezista darunavir ethanolate Suspension;Oral Janssen Prods Labeling Revision
Reyataz atazanavir sulfate Capsule;Oral Bristol Myers Squibb Labeling Revision
Reyataz atazanavir sulfate Powder;Oral Bristol Myers Squibb Labeling Revision
Saxenda liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Labeling Revision
Sustiva efavirenz Capsule;Oral Bristol Myers Squibb Labeling Revision
Sustiva efavirenz Tablet;Oral Bristol Myers Squibb Labeling Revision
Tekamlo aliskiren hemifumarate; amlodipine besylate Tablet;Oral Novartis Labeling Revision
Tekturna aliskiren hemifumarate Tablet;Oral Novartis Labeling Revision
Tekturna Hct aliskiren hemifumarate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision
Viracept nelfinavir mesylate Powder;Oral Agouron Labeling Revision
Viracept nelfinavir mesylate Tablet;Oral Agouron Labeling Revision
Viracept nelfinavir mesylate Tablet;Oral Agouron Labeling Revision