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About 804 results for "Fda Good Manufacturing Practices"

BRIEF-Formycon completes GMP inspection, prepares for FYB201 p...

March 9 (Reuters) - Formycon AG : * Announces successful GMP (Good Manufacturing Practices)inspection and the start of U.S. FDA scientific advice procedure for its out-licensed biosimilar FYB201 * This achievement is another important step in ... Reuters UK, 2 weeks ago

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FDA News

FDA Lengthens Comment Period on GMP Requirements for Combo Products

Drugmakers now have until April 29 to comment on the FDA's draft guidance on current good manufacturing practices for combination products. The original deadline for comments on Docket No. FDA-2015-D-0198 was March 30. However, the agency says ...
 FDA News1 week ago CGMPs for Combination Products - Understanding and Applying FDA's Draft Guidance (Webcast)  Regulatory Affairs Professionals Society1 week ago FDA releases final guidance on reprocessing of reusable medical devices  Mr Top Step2 weeks ago FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices  JD Supra2 weeks ago

Thorne Research Announces NSF Certification

Good manufacturing practices (GMPs) are guidelines that assist companies in developing and maintaining proper controls in their manufacturing process so that products are processed, manufactured and labeled in a consistent manner, and meet quality ...
 World Energy Source1 week ago

The Apotex Case: Current Good Manufacturing Practices (cGMP) violations

Here is a company you probably never heard of, Apotex. Chances are good, however, they manufactured a vaccine you received from your doctor. The company generates a billion dollars a year in sales, manufacturers more than 300 different ...
 National Law Review3 weeks ago Quincy Bioscience Earns NSF Good Manufacturing Practice (GMP) Recertification  Benzinga.com3 weeks ago

ASEAN Association of South East Asian Nations : Moves Sectoral MRA on Good Manufacturing Practices Forward

- Healthcare, which includes the pharmaceutical sector, is one of 12 priority sectors for ASEAN economic integration. In line with this, an ASEAN Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) Inspection for Manufacturers ...
 4 Traders1 week ago ASEAN imposes tighter medicine and pharmaceutical management  VietnamPlus1 week ago

Managing Supplier Data Collection

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices. Q. Our engineering department is managed by a small team of professionals who supervise and manage a large number of service suppliers that ...
 PharmTech.com3 weeks ago

FDAnews Announces: Conducting Effective Internal Quality Audits:...

It's estimated that 75% of device manufacturers conduct internal audits solely because we have to because the FDA and ISO regs say so. In just 90 minutes, attendees will be shown why internal audits should be used as a proactive tool and not just ...
 PRWeb2 weeks ago QUALITY SYSTEMS : FDAnews Announces: Conducting Effective Internal Quality Audits: Device Guru Shares 25 Years of Experience Webinar, March 26, 2015  4 Traders2 weeks ago Conducting Effective Internal Quality Audits: Device Guru Shares 25 Years of Experience  FDA News3 weeks ago

FDAnews Announces: FDA's New Inspection Approach: What Your Inspector Knows in Four Hours Webinar, March 24, 2015

PRWeb FDA's New Inspection Approach: What Your Inspector Knows in Four Hours **FDAnews Webinar** March 24, 2015 -- 1:30 p.m. - 3:00 p.m. EDT FDA investigators generally know within four hours of ...
 Town Hall3 weeks ago FDAnews Announces: FDAs New Inspection Approach: What Your Inspector Knows in Four Hours Webinar, March 24, 2015  Review Seeker3 weeks ago
Bioscience Technology Online

Non-FDA Approved Hormone Therapies on the Rise

Use of potentially risky, non-FDA approved hormone therapies may soon be as common as use of FDA-approved hormone therapies, according to a study by University of Virginia gynecology researcher JoAnn Pinkerton. Between 28 and 68 percent of ...
 Bioscience Technology Online6 days ago US FDA expects Indian pharma to seek third party audits to resolve data integrity issues  PharmaBiz6 days ago U.S. FDA softens approach in meetings with Indian regulators  Fierce Drug Delivery1 week ago India's Wockhardt, Granules, suggest recent FDA inspections went well  Fierce Biotech Research1 week ago
Bio Spectrum Asia

GE, Siemens recall MRI machines

Singapore : FDA has recalled nearly 10,000 GE and Siemens MRI machines, classifying the recalls under second serious Class II category-meaning the affected machines "may cause temporary or medically reversible adverse health consequences." ...
 Bio Spectrum Asia3 days ago UPDATED: Nearly 10,000 GE, Siemens MRI machines under FDA recall  FierceMedicalDevices4 days ago FDA targets GE, Siemens MRIs in Class II recalls  Cardiovascular Business5 days ago
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