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Drug Product

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Name: Drug Product

First reported 3 hours ago - Updated 3 hours ago - 1 reports

AAPS Webinar to Highlight Approaches to the Investigation of Dissolution Testing Changes and Failures

AAPS Press Release (05/21/2013)body: The American Association of Pharmaceutical Scientists (AAPS) is pleased to present a free eLearning webinar "Approaches to the Investigation of Dissolution Testing Changes and Failures." This presentation, held May ... [Published AAPS Pharmceutica - 3 hours ago]

Entities: Dissolution, Drug Product, Investigation

First reported 19 hours ago - Updated 5 hours ago - 1 reports

Boehringer Ingelheim GmbH

FDA warns Boehringer-Ingelheim over cGMP failings

The FDA has sent a warning letter to Boehringer-Ingelheim over cGMP violations at its active pharmaceutical ingredient (API) and finished pharmaceutical manufacturing facility at Ingelheim am Rhein, Germany, following an inspection in November 2012.On ... [Published Manufacturing Chemist - 19 hours ago]

Entities: Boehringer Ingelheim GmbH, FDA Food & Drug Administration, Manufacturing, Michael Smedley, Spiriva HandiHaler

First reported May 21 2013 - Updated May 21 2013 - 1 reports

05.21.13 -- Is Your Document Control System Out Of Control?

APIs are synthesized via key filtration and separation steps to produce a high-quality drug product. To improve process efficiency, you should select filtration technologies that are scalable to ensure reproducible results from the lab to process development, ... [Published Pharmaceutical Online - May 21 2013]

Entities: Filtration, Drug Product

First reported May 21 2013 - Updated May 21 2013 - 1 reports

FDA Food & Drug Administration

FDA is Asked to Deviate From ANDA “Exception Excipient” Policy for Generic VFEND Injection; Precedent Indicates Agency Will Reamin Firm

By Kurt R. Karst –A Citizen Petition (Docket No. FDA-2013-P-0203) submitted to FDA earlier this year raises an issue that comes up from time to time – although not typically in a public forum – about the Agency’s so-called “exception excipient” regulations ... [Published FDA Law Blog - May 21 2013]

Entities: FDA Food & Drug Administration, Excipient, Vfend

First reported May 20 2013 - Updated May 20 2013 - 1 reports

California State Assembly

AB-670 Targets Pharmacist Kickback Schemes

California State Assembly Bill AB-670 aims to close a loophole in state law that allows health insurers to give a financial kickback to pharmacists every time they decide to give customers cheaper, poorer quality drugs that are not chemically equivalent ... [Published California Broker Magazine - May 20 2013]

Entities: Pharmacist, Drug Product, Toni Atkins, California State Assembly, Active Ingredient

First reported May 20 2013 - Updated May 20 2013 - 1 reports

New Guidance on Geriatric Labeling

Manufacturers now have a tool clarifying a 1997 rule on labeling statements regarding geriatric use of drugs and biologics.FDA has released a new guidance on how to submit information for the "Geriatric Use" subsection of the labeling for prescription ... [Published Pharmaceutical & Medical Packaging News - May 20 2013]

Entities: Geriatrics, Drugs, Supplement, Drug Product, Biology

First reported May 18 2013 - Updated May 18 2013 - 1 reports

Directorate of pharmacy need to be established in each state to check drug related matters

To address the issues related to drugs and other pharmaceutical products and also to ensure the quality of medicines manufactured and supplied, separate directorate of pharmacy (ED) should be established in each state under health departments.Unless there ... [Published PharmaBiz - May 18 2013]

Entities: Drugs, Drug Product, Toxic, Relativity, R.S. Corp Ltd

First reported May 18 2013 - Updated May 18 2013 - 1 reports

Extractables and Leachables: Best Practices to Ensure Patient Safety

Next » When developing a drug product, it is vital to ensure the product that reaches patients has not been contaminated or adulterated in any way by its packaging. Although the risk is low for solids, such as tablets and capsules, with liquid injectable ... [Published BioPharm International - May 18 2013]

Entities: Extractables, Chemical, Patient Safety

First reported May 18 2013 - Updated May 18 2013 - 1 reports

HCPC Winners Focus on Innovation

The NextBottle features a dial with a mechanism counting the days of the week.The Healthcare Compliance Packaging Council (Falls Church, VA) announced the winners of its 2007 Compliance Package of the Year competition on April 4. The awards consist of ... [Published Pharmaceutical & Medical Packaging News - May 18 2013]

Entities: Blister, Effexor, Sharp Corporation, Titration

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Biologic Drugs Subject of AAPS Workshop

AAPS Press Release (05/09/2013)body: The American Association of Pharmaceutical Scientists (AAPS) is pleased to present the AAPS Workshop on Biologic Drugs: Recent Trends in Formulation, Manufacture and Characterization. This event is part of the pre-conference ... [Published AAPS Pharmceutica - May 17 2013]

Entities: Biologics, Drugs, Drug Product

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Firms Answer Call for Packaging Personnel

These days, pharmaceutical and medical device firms are willing to contract out more and more functions, including packaging. It is not surprising, then, that some are contracting for packaging designers and engineers.There is even a firm, Equity Packaging ... [Published Pharmaceutical & Medical Packaging News - May 17 2013]

Entities: McNeil Consumer Healthcare, Drug Product, Health Care, Michigan State University, University School

First reported May 16 2013 - Updated May 16 2013 - 1 reports

Multivariate Approaches for Powder Characterization

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.Pharmaceutical Sciences, Manufacturing & Marketplace ReportAlthough traditional powder-characterization ... [Published Pharmaceutical Technology - May 16 2013]

Entities: Manufacturing, Marketplace, Pharmaceutical Product Development Inc, Drug Product

Quotes

body: The American Association of Pharmaceutical Scientists (AAPS) is pleased to present a free eLearning webinar "Approaches to the Investigation of Dissolution Testing Changes and Failures." This presentation, held May 23 from 12:30 PM to 2:00 PM ET, is organized by the AAPS In Vitro Release and Dissolution Testing focus group and will be...

AAPS Webinar to Highlight Approaches to the Investigation of Dissolution Testing Changes and Fail ... [Published AAPS Pharmceutica - 3 hours ago]

More From BioPortfolio on "Protalex Reports Positive Interim Review of Phase 1b Trial of PRTX-100 in Rheumatoid Arthritis by Independent Data Safety Monitoring Committee"

Protalex Reports Positive Interim Review of Phase 1b Trial of PRTX-100 in Rheumatoid Arthritis by ... [Published BioPortfolio - 23 hours ago]

...efavirenz, emtricitabine and tenofovir Disoproxil fumarate tablets, 600 mg/200 mg/300 mgAgency Reviews Patent Application Approval Request for "Methods for Treatment of HIV and Other Infections Using a T Cell Or Viral Activator and Anti-Retroviral Combination Therapy" New Superiority Trial Showed LIVALO® pitavastatin 4 mg Provided Significantly Greater LDL-C Reduction in HIV-Infected Adults with Dyslipidemia versus...

Tentative approval of lamivudine and tenofovir disoproxil fumarate Tablets, 300 mg/300 mg [Published AEGIS - May 22 2013]

...diagnosis of Parkinsonian Syndromes and Dementia with Lewy Bodies," stated Thomas Tulip, PhD, Navidea's President and Chief Business Officer. "Nordion has extensive expertise in high quality production of 123I radiopharmaceuticals and a world class distribution system to reliably manage logistics to ensure that radiolabeled NAV5001 reaches clinical trial site destinations according to rigorous standards."

Navidea Biopharmaceuticals Enters into Manufacturing and Sup. . . [Published Equities.com - May 21 2013]

More Content

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AAPS Webinar to Highlight Approaches to the Inv... [Published AAPS Pharmceutica - 3 hours ago]
FDA warns Boehringer-Ingelheim over cGMP failings [Published Manufacturing Chemist - 19 hours ago]
Protalex Reports Positive Interim Review of Pha... [Published BioPortfolio - 23 hours ago]
Malvern Instruments Announces Global Agreement ... [Published Select Science - May 22 2013]
Cumberland Pharma On The Right Track... But Mov... [Published Seeking Alpha - May 22 2013]
Tentative approval of lamivudine and tenofovir ... [Published AEGIS - May 22 2013]
Synergy Is A Straightforward Opportunity: Trial... [Published Seeking Alpha - May 21 2013]
05.21.13 -- Is Your Document Control System Out... [Published Pharmaceutical Online - May 21 2013]
Malvern Instruments Announces Global Agreement ... [Published Pharma-Mag - May 21 2013]
FDA is Asked to Deviate From ANDA “Exception Ex... [Published FDA Law Blog - May 21 2013]
Navidea Biopharmaceuticals Enters into Manufact... [Published Equities.com - May 21 2013]
Navidea Biopharmaceuticals Enters into Manufact... [Published Individual.com - May 21 2013]
AB-670 Targets Pharmacist Kickback Schemes [Published California Broker Magazine - May 20 2013]
Immune Response BioPharma Sets Pricing of REMUN... [Published BioSpace - May 20 2013]
While We’re Waiting on Bartlett, Some New Preem... [Published FDA Law Blog - May 20 2013]
Multisorb To Exhibit The Strippax And Stabilox ... [Published Pharmaceutical Online - May 20 2013]
All sterile drug products from NuVision Pharmac... [Published News-Medical.Net - May 20 2013]
New Guidance on Geriatric Labeling [Published Pharmaceutical & Medical Packaging News - May 20 2013]
End-to-end pharmacovigilance is a must–Unilab [Published Business Mirror - May 19 2013]
Promoting Dosing Accuracy with Prefilled Syringes [Published Pharmaceutical & Medical Packaging News - May 19 2013]
FDA expands alert to health care providers abou... [Published Ein News - May 18 2013]
Extractables and Leachables: Best Practices to ... [Published BioPharm International - May 18 2013]
HCPC Winners Focus on Innovation [Published Pharmaceutical & Medical Packaging News - May 18 2013]
Directorate of pharmacy need to be established ... [Published PharmaBiz - May 18 2013]
Transition to Propellant-Free CombiventÂ® Respi... [Published TickerTech.com - May 17 2013]
New Solutions Address Change [Published Pharmaceutical & Medical Packaging News - May 17 2013]
Biologic Drugs Subject of AAPS Workshop [Published AAPS Pharmceutica - May 17 2013]
Firms Answer Call for Packaging Personnel [Published Pharmaceutical & Medical Packaging News - May 17 2013]
Understanding ICH Q11—FDA's Guidance on the Dev... [Published Pharmaceutical Technology - May 17 2013]
Multivariate Approaches for Powder Characteriza... [Published Pharmaceutical Technology - May 16 2013]

Blogs

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Malvern Instruments Announces Global Agreement ... [Published Pharma-Mag - May 21 2013] Malvern Instruments, a leader in the field of pharmaceutical material characterization, has announced a global agreement with Proveris Scientific Corporation, a company with complementary technology for orally inhaled and nasal drug product (OINDP) testing, ...
FDA is Asked to Deviate From ANDA “Exception Ex... [Published FDA Law Blog - May 21 2013] By Kurt R. Karst –A Citizen Petition (Docket No. FDA-2013-P-0203) submitted to FDA earlier this year raises an issue that comes up from time to time – although not typically in a public forum – about the Agency’s so-called “exception excipient” regulations ...
While We’re Waiting on Bartlett, Some New Preem... [Published FDA Law Blog - May 20 2013] By Kurt R. Karst –As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought ...
FDA Determines Original OPANA ER Not Discontinu... [Published FDA Law Blog - May 13 2013] By Kurt R. Karst –Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) ...
FDA Appeals PLAN B Ruling to the Second Circuit... [Published FDA Law Blog - May 03 2013] By Kurt R. Karst –By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District of ...

Press Releases

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Stem Cell Therapeutics Announces Completion of ... [Published PR inside - May 16 2013]
Navidea Biopharmaceuticals Signs Manufacturing ... [Published Business Wire - May 15 2013]
Navidea Biopharmaceuticals Signs Manufacturing ... [Published EON Business - May 15 2013]
Navidea Biopharmaceuticals Signs Manufacturing ... [Published Business Wire Health News - May 15 2013]
Japanese Pharmaceutical Industry Reviewed by GB... [Published Business Wire - May 07 2013]