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About 811 results for "Fda Good Manufacturing Practices"

Wockhardt dips after the US FDA asks to recall drugs
Business Standard

FDA Finds Deviations in Bio-Rad's cGMP Practices

An FDA inspection of Bio-Rad's Medical Diagnostics GmbH unit in Dreieich, Germany revealed gaps in the company's current good manufacturing practices, according to a notice on FDA's website. The letter specifically calls attention to various open ... BioPharm International, 1 day ago

FDA Bans India Drug Plant For Violating Manufacturing Standards

Emcure Pharmaceuticals' plant in Maharashtra, India, reportedly violated good manufacturing practice standards, according to the FDA. By Suzette Gutierrez | Jul 15, 2015 12:34 PM EDT FDA's import alert on drugs manufactured by Emcure was ...
 Hngn.com2 weeks ago FDA bans drug imports from Indian plant  Pharmafile1 week ago FDA Puts One More Indian Drugmaker on Import Ban List  FDA News1 week ago FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint  JD Supra2 days ago
Medical Design Online

Combination Product cGMPs: Your Compliance Strategy

Read expert advice on how to implement FDA's rule on current Good Manufacturing Practices for combination products. Mary C. Getz, PhD, Olivia Wong, D. Michelle Garrett, and W. Ben Shand In January 2013, the FDA's Office of Combination ...
 Medical Device & Diagnostic Industry1 week ago Politicians Want to Fix Combination Product Regs  Medical Device & Diagnostic Industry1 week ago Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015  JD Supra1 week ago U.S. Sens File Bill To Streamline Combination Products Regulation  Medical Design Online1 week ago
Natural Products Industry Insider

The ABCs of GMP Compliance

It's been eight years since FDA published its final rule regarding GMPs (good manufacturing practices) for dietary supplements. Still, this late in the game, many are perplexed about what the regulations are asking for. There are still ...
 Natural Products Industry Insider1 week ago Heliocare Earns NSF Good Manufacturing Practice Registration For IFC Manufacturing Facility  DermWire2 weeks ago

7/6/15 - Unique Pharmaceuticals Approved by Florida State Board of Pharmacy for Sterile Distribution

By a News Reporter-Staff News Editor at Pharma Business Week UNIQUE PHARMACEUTICALS, a 503B current Good Manufacturing Practices (CGMP) Outsourcing Facility, announced its licensure approval in Florida. The Florida State Board of Pharmacy review ...
 Pharmacy Choice3 weeks ago Two ends of the pharma spectrum  Livemint.com1 week ago Lupin's Goa unit comes under USFDA scanner  Economic Times5 days ago Indian Pharmaceutical Company Faces Heat From Health Regulatory Authorities In The US  MedIndia1 week ago
Sys-Con Media

Pace Wellness Enters Into Acquisition Agreement For Breakthrough Oral Thin-Film Technology

Pace has everything in place to develop new products from its regulatory-compliant FDA and cGMP (Current Good Manufacturing Practices) manufacturing facility in California The OTF drug delivery platform technology opens up boundless opportunities ...
 Pettinga Financial Advisors1 week ago Pace Wellness to Buy Oral Thin-Film Technology from Manufacturing Partners  Bloomberg1 week ago

Elements of Current Good Manufacturing Practices (cGMP) for Complying with the Food Safety Modernization Act (FSMA): 2-Day In-Person Seminar (Orlando, FL)

In this two day workshop conference you will learn the various rules regulating the development, manufacturing and quality assurance of products manufactured for animals and humans, the basis of Hazard analysis and critical control points (HACCP) ...
 Research and Markets6 days ago

FDA Quality Metrics Offer Regulatory Carrots for Manufacturers

Biopharmaceutical companies able to produce high quality drugs and biologics on a regular basis may merit less frequent plant inspections and reduced reporting of post-approval manufacturing changes, based on a set of quality metrics indicating ...
 PharmTech.com8 hours ago

The compounding regulations surrounding drug compounding

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in manufactured form, such as ...
 Lexology5 days ago

Wearable gizmos vs. medical devices: how companies can comply with FDA security recommendations

Kaye Scholer Counsel Helen Christakos, whose practice areas include intellectual property, technology and data security, discusses the U.S. Food and Drug Administration's recent decision not to closely regulate so-called general wellness products ...
 Lexology1 week ago
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