Top 15 quotes from Facebook CEO Mark Zuckerberg's townhall at IIT Delhi

Click the following link for more details :                                                      15 Quotes by Mark Zuckerbe...

FDA’s History of Withdrawing Warning Letters

Follow the link given below for more details : http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/10/warning-letter-what-warning-letter-latest-developments-in-pacira-and-a-look-at-fdas-history-of-withd.ht...

The 1937 Elixir Sulfanilamide Incident - Taste of Death

In 1937, the S.E. Massengill Company of Bristol, Tennessee, began selling bottles of Elixir Sulfanilamide, a liquid version of a popular antibiotic of the day. But more than 100 people died after taking the drug, and investigators from the US Food and Drug Administration...

General Concepts of the Ph.Eur

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Medicines - Life Saving Drugs

Click the link given below: https://drive.google.com/file/d/0B5tIOyloMuGvVW1iX3BILUpWTGc/view?usp=sharing...

Creativity & Innovation

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DRUG APPROVAL—BRINGING A NEW DRUG TO THE MARKET (FDA Case Study)

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Solubility Concerns: API and Excipient Solutions

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India woos Italian bulk drug makers to cut dependency on Chinese APIs

HYDERABAD: The government is looking to promote, domestic pharma companies' tieups with bulk drug makers in Italy to cut dependence on China for pharmaceutical ingredients.  India sources over 70 per cent of its requirement of bulk drugs (ingredients) from...

WISH YOU ALL HAPPY DASARA FESTIVAL

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QC Laboratory at a Glance

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Good and Bad Responses to 483s

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Indian Government Initiatives For The Development of Pharma Industry

The Addendum 2015 of the Indian Pharmacopoeia (IP) 2014, published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, is expected to play a significant role in enhancing the quality of medicines that would in turn...

China luring Indian pharma scientists with 3 times higher pay to boost formulations segment

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Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength

AUDIENCE: Pharmacy, Consumer ISSUE: On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen...

FAQ about the FDA Drug Approval Process

  Q: Why are drugs evaluated by the FDA? A: Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by...

How the FDA Approval Process Works

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The Merging of Medical Products

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Good Laboratory Practice

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FDA's New Overseas Leaders

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Good manufacturing practice (GMP) requirements for pharmaceutical excipients

   Click below link :    https://drive.google.com/file/d/0B5tIOyloMuGvc2hkUjMyZVYxQmM/view?usp=sharing  &nbs...

How the elements got their names

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The Ten Worst Drug Recalls In The History Of The FDA

1) Fenfluramine/phentermine (Fen-Phen) Wyeth-Ayerst Laboratories Recalled: 1997 (after 24 years on the market) Financial damage: Awards to victims close to $14 billion, making it one of the most costly products liability cases in history. Fen-Phen’s was a hugely...

Government to set up R&D centre for bulk drugs at NIPER

Link : http://www.business-standard.com/content/b2b-pharma/government-to-set-up-r-d-centre-for-bulk-drugs-at-niper-114071500616_1.html...

The Difference Between Successful And Unsuccessful People

Click below link: The Difference Between Successful And Unsuccessful Peop...

Q3D Elemental Impurities

Click below link :  https://drive.google.com/file/d/0BzX1tuvsApriUjZGR2V3VmxDTEU/view?usp=sharing...

Merck, BD Face Issues With Drug Container Closures

Merck is recalling thousands of bottles of Temodar and temozolomide capsules because cracks in the caps have rendered the child-resistant closure ineffective.   The recall affects roughly 276,000 five- and 14-count bottles of the oral chemotherapy drugs, which...

Judge Says Marketing Exclusivity Begins With FDA Sign-Off on Drug

A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs. Click below link :  http://www...

Karl Fischer Titration - Metrohm Ltd

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MHRA, CDSCO Sign Agreement to Increase Regulatory Collaborations

Click below link : http://www.raps.org/Regulatory-Focus/News/2015/10/05/23328/MHRA-CDSCO-Sign-Agreement-to-Increase-Regulatory-Collaboration...

FDA to Accept Draft Labeling to Support Abbreviated New Drug Application Approvals

Click below link http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM465628.pdf?source=govdelivery&utm_medium=email&utm_source=govdelive...

Writing An Effective 483 Response

Click below link : https://drive.google.com/file/d/0BzX1tuvsAprib2pWbXhjUHdfZ2s/view?usp=shari...

Quality Metrics - FDA plan

Click below link : https://drive.google.com/file/d/0BzX1tuvsApriaDRudVNHQW9WSWc/view?usp=shari...

Clinical Trials - Research to Public Health

Click on the link to read : https://drive.google.com/file/d/0BzX1tuvsApriU1hxN3BtdHdwRU0/view?usp=shari...

Upcoming bulk drug policy could trigger investments worth Rs 40,000 cr

Link : http://www.business-standard.com/article/companies/upcoming-bulk-drug-policy-could-trigger-investments-worth-rs-40-000-cr-115062900720_1.ht...

India Must Reduce Reliance On China For Bulk Drugs: Indian Drug Manufacturers Association

Link : http://www.medindia.net/news/india-must-reduce-reliance-on-china-for-bulk-drugs-indian-drug-manufacturers-association-153049-1.ht...

Dr. Anji Reddy Kallam - Pioneer of Indian Pharmaceutical Industry

Click below link for details: https://drive.google.com/file/d/0BzX1tuvsApriMDlhZUpxSlhvMDQ/view?usp=sharin...

FDA revokes approval for Sun Pharma's seizure drug over compliance issues

The US Food and Drug Administration has revoked an approval issued in March to Sun Pharma Advanced Research Company (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site. The move comes as a setback to SPARC, the research...

India Seeks to Amend Pharma Manufacturing Laws to meet Export Standards

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