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About 799 results for "Fda Good Manufacturing Practices"

The FDA Sees a Problem with Valeant's New Glaucoma Eye Drops
Fortune

BRIEF-Valeant says no safety concerns, additional clinical tri...

July 22 Valeant Pharmaceuticals International Inc * Concerns raised by fda pertain to good manufacturing practice inspection at bausch+lomb's facility in florida where deficiencies were identified * Valeant pharmaceuticals receives complete ... Reuters UK, 2 days ago
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Valeant Pharma Receives FDA Letter Related To CGMP At Bausch + Lomb Facility

The company said the concerns raised by the FDA pertain to a Current Good Manufacturing Practice inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified. For comments and feedback:
 Nasdaq2 days ago
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PharmTech.com

Data Integrity Challenges in Manufacturing

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program. VICTOR HABBICK VISIONS/SCIENCE PHOTO LIBRARY/ Data integrity, which refers to the ...
 PharmTech.com2 weeks ago
Slate Magazine

Manufacturing issues thwart FDA approval for Valeant eye drug

It had been a good week Valeant ($VRX) after an FDA panel backed its skin drug brodalumab and then the regulator gave the thumbs up for an oral version of its constipation drug Relistor--but its good fortune has come to an end as the FDA has today ...
 FierceBiotech2 days ago Fresh off Relistor win, Valeant hits FDA roadblock for eye drug  BioPharma Dive2 days ago The FDA's Abstinence-Only Approach to Eating Cookie Dough Is Unrealistic and Alarmist  Slate Magazine3 weeks ago

Suven facility gets FDA inspection report

The US Food and Drug Administration has issued an Establishment Inspection Report for Suven Life Sciences facility at Pashamylaram, near Hyderabad. The company had undergone USFDA renewal inspection at the facility that manufactures and supplied ...
 The Hindu3 days ago Ensuring Supply Chain Safety  PharmTech.com2 weeks ago

FDA and Manufacturers Intensify Concerns about Data Integrity

Agency guidance and industry standards aim to reduce lapses and improve quality operations. FDA has long emphasized the importance of reliable and accurate data in ensuring drug safety, quality, and purity, but current good manufacturing practice ...
 PharmTech.com2 weeks ago
StatNews.com

Pharmalot, Pharmalittle: FDA overlooks troubles at Chinese supplier to avoid shortages

And so, another working week will soon draw to a close. This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. Besides hoping to keep cool, we plan to catch up on sundry chores and errands, hang ...
 StatNews.com2 days ago FDA provides more guidances for compounding pharmacies; HHS worries about volume growth  Pharmaceutical Commerce1 week ago FDA Must Do More To Ensure Safety Of Compound Drugs  Huffington Post3 weeks ago

New FDA Guidance Documents Seek to Limit Scope of Compounding

Drugs that are manufactured at large scale are typically limited to a particular dosage or formulation, and sometimes these parameters do not suit all the needs of the patients who are candidates for treatment with that drug. For patients who are ...
 BioPharm International2 weeks ago

Chinese Manufacturer Receives Warning Letter

FDA issued a warning letter to Guangzhou Haishi Biological Technology Co., Ltd. on June 22, 2016, stating the company had violated current good manufacturing practice (CGMP) regulations at its Guangdong facility. The letter addresses the company's ...
 BioPharm International2 weeks ago

Justice helps FDA shut down noodle and sprout distribution

(Before It's News) U.S. Food and Drug Administration (FDA) inspectors began recording the failure to properly maintain the Kwong Tung Foods facility at 1840 East 38th Street in Minneapolis in 2010. Pipes were observed draining directly onto ...
 Before It's News6 days ago FDA inspections of rice, noodle makers find hygiene issues  Taipei Times Online2 weeks ago
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