tag:blogger.com,1999:blog-12821798520892391042024-03-13T22:45:22.750+05:30TRACK REGULATORYAnonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.comBlogger260125tag:blogger.com,1999:blog-1282179852089239104.post-81615603792205892752015-04-02T10:24:00.005+05:302015-04-02T10:24:48.104+05:30USFDA 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 Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-39934376778496604672015-04-02T10:10:00.004+05:302015-04-02T10:10:57.624+05:30USFDA: 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 Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-30017240373879233302015-04-01T17:06:00.000+05:302015-04-01T17:06:12.454+05:30New 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 Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-75110767450960504312015-04-01T16:57:00.001+05:302015-04-01T16:57:33.066+05:30UK 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:
CLICK HERE
Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-4699349499367680672015-04-01T16:49:00.001+05:302015-04-01T16:52:01.953+05:30USFDA 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 Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-71149932673002839412015-04-01T16:45:00.000+05:302015-04-01T16:45:17.891+05:30USFDA : 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 circumstancesAnonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-82895442797052447502015-04-01T16:38:00.000+05:302015-04-01T16:40:05.636+05:30USFDA: 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
Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-72152004892552410782014-12-19T11:42:00.001+05:302015-04-01T16:40:17.901+05:30USFDA: New and Generic Drug Approvals: 25 NOV 2014
New and Generic Drug Approvals
November 25, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxilamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSandozLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet;OralApotex IncLabeling Revision
Bupropion Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-40901875052408878812014-12-19T11:41:00.000+05:302014-12-19T11:41:01.583+05:30USFDA: New and Generic Drug Approvals: 24 NOV 2014
New and Generic Drug Approvals
November 24, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acanyabenzoyl peroxide; clindamycin phosphateGel;TopicalDow PharmEfficacy Supplement with Clinical Data to Support
Byettaexenatide syntheticInjectable;SubcutaneousAstrazeneca AbEfficacy Supplement with Clinical Data to Support
Diclofenac Sodiumdiclofenac sodiumSolution;Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-16362778148690992932014-12-19T11:39:00.000+05:302014-12-19T11:39:04.138+05:30USFDA: New and Generic Drug Approvals: 21 NOV 2014
New and Generic Drug Approvals
November 21, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adcetrisbrentuximab vedotinInjectable; InjectionSeattle GeneticsLabeling Revision
Cardizemdiltiazem hydrochlorideTablet;OralValeant IntlLabeling Revision
Hydrocodone Bitartrate and Homatropine Methylbromidehomatropine methylbromide; hydrocodone bitartrateSyrup;OralActavis MidAnonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-64322755443761869202014-12-19T11:35:00.002+05:302014-12-19T11:35:54.072+05:30CFSAN Constituent Update - FDA Issues Final Menu and Vending Machine Labeling Requirements
The U.S. Food and Drug Administration has finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments and vending machines to help consumers make informed decisions about meals and snacks.
The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-26553694511729723382014-12-19T11:30:00.002+05:302014-12-19T11:30:46.829+05:30USFDA: New and Generic Drug Approvals: 20 NOV 2014
New and Generic Drug Approvals
November 20, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aleve Pmdiphenhydramine hydrochloride; naproxen sodiumTablet;OralBayer HlthcareLabeling Revision
Aveloxmoxifloxacin hydrochlorideTablet;OralBayer HlthcareLabeling Revision
Avelox In Sodium Chloride 0.8% In Plastic Containermoxifloxacin hydrochlorideInjectable;Iv (Infusion)Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-31198222802693488552014-12-19T11:29:00.000+05:302014-12-19T11:29:36.127+05:30CDRH Industry: Guidance for Industry and Food and Drug Administration Staff - Design Considerations for Devices Intended for Home Use
This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements.
Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-90234310043706573382014-12-19T11:25:00.000+05:302014-12-19T11:25:04.075+05:30Health Canada : Consumer Product Update: Health Canada Warns of Fire Risk to Oxygen Therapy Patients from Electronic Cigarettes and Other Electrical Devices
Health Canada has been notified of an incident in the Province of Quebec resulting in an injury to a consumer from a fire associated with the use of an electronic cigarette in the presence of an oxygen source.
According to the information currently available, the injured individual was undergoing oxygen therapy at the time of the incident.
Health Canada is aware of similar Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-28460304905955993082014-12-19T11:21:00.001+05:302014-12-19T11:21:57.995+05:30USFDA Recall - Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Complaints of Empty Capsules...
ISSUE: Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.
Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-32997791173708200282014-12-19T11:06:00.000+05:302014-12-19T11:06:14.928+05:30FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-28309892555330546182014-12-19T10:58:00.002+05:302014-12-19T10:58:38.002+05:30USFDA : Manual of Policies and Procedures - Chemistry Review of Question-based-Review (QbR) of Submissions...
USFDA has updated Manual of Policies and Procedures Document Titled "Chemistry Review of Question-based-Review (QbR) of Submissions".
To Download the Document Please CLICK HERE
Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-20494915623692831962014-12-19T10:54:00.004+05:302014-12-19T10:54:44.032+05:30USFDA: New and Generic Drug Approvals: 18 NOV 2014
New and Generic Drug Approvals
November 18, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Children's Fexofenadine Hydrochloride Allergyfexofenadine hydrochlorideSuspension;OralActavis Mid AtlanticApproval
Children's Fexofenadine Hydrochloride Hivesfexofenadine hydrochlorideSuspension;OralActavis Mid AtlanticApproval
Fexofenadine Hydrochloride and Pseudoephedrine Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-23066082814088962842014-12-19T10:47:00.002+05:302014-12-19T10:47:55.006+05:30MHRA Monthly list of granted marketing authorisations: Marketing authorisations granted in October 2014
Title:
Marketing Authorization Granted in Oct 2014
Summary
Details of marketing authorisations (MAs) granted in October 2014.
To Download the List CLICK BELOW LINK
Marketing authorisations granted in October 2014
Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-57772746985981726052014-12-19T10:44:00.000+05:302014-12-19T10:44:02.580+05:30USFDA Medical Device Safety and Recalls: Respironics California, Esprit V1000 and V200 Ventilators - Power Failure May Occur...
A recall has been issued for Respironics California, Esprit V1000 and V200 Ventilators because power failure may occur. The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com1tag:blogger.com,1999:blog-1282179852089239104.post-73010957530529463012014-12-19T10:41:00.000+05:302014-12-19T10:51:12.174+05:30USFDA - Deadline for Registration and Listing of Medical Devices Manufacturers...
It’s registration and listing time! All medical device establishments are required to pay the annual registration user fee and re-register their establishments by December 31, 2014.
FDA’s Center for Devices and Radiological Health (CDRH) has a new tutorial that explains how to register a domestic establishment for the first time in the FURLS (FDA’s Unified Registration Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-55247145011829814252014-11-19T13:33:00.001+05:302014-11-19T13:33:12.830+05:30USFDA: New and Generic Drug Approvals: 17 NOV 2014
New and Generic Drug Approvals
November 17, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cutivatefluticasone propionateLotion;TopicalFougera PharmsManufacturing Change or Addition
Hepatamine 8%amino acidsInjectable;InjectionB BraunManufacturing Change or Addition
Nucyntatapentadol hydrochlorideSolution;OralJanssen PharmsLabeling Revision
PegintronpeginterferonAnonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-56072629418354894982014-11-19T13:31:00.002+05:302014-11-19T13:31:38.426+05:30USFDA: New and Generic Drug Approvals: 16 NOV 2014
New and Generic Drug Approvals
November 16, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Choline C-11choline c-11Injectable;IntravenousMcprfManufacturing Change or Addition
Fiorinal W/Codeineaspirin; butalbital; caffeine; codeine phosphateCapsule;OralWatson Labs IncManufacturing Change or Addition
Injectaferferric carboxymaltoseInjectable;Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-12953745789245414792014-11-19T12:49:00.002+05:302014-11-19T12:49:30.543+05:30USFDA: New and Generic Drug Approvals: 15 NOV 2014
New and Generic Drug Approvals
November 15, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ferric Citrateferric citrateTablet;OralKeryx BiopharmsLabeling Revision
Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0tag:blogger.com,1999:blog-1282179852089239104.post-58208109945946580572014-11-19T12:47:00.002+05:302014-11-19T12:47:50.036+05:30USFDA: New and Generic Drug Approvals: 14 NOV 2014
New and Generic Drug Approvals
November 14, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AndrogeltestosteroneGel, Metered;TransdermalAbbvieLabeling Revision
AndrogeltestosteroneGel;TransdermalAbbvieLabeling Revision
AvastinbevacizumabVial; IntravenousGenentechEfficacy Supplement with Clinical Data to Support
CampathalemtuzumabVial; IntravenousIlex Anonymoushttp://www.blogger.com/profile/14307307174537076395noreply@blogger.com0