Top 15 quotes from Facebook CEO Mark Zuckerberg's townhall at IIT Delhi
Categories:
Inspiring Personalities
Saturday, October 31, 2015
Friday, October 30, 2015
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.html
Categories:
Industry News
Thursday, October 29, 2015
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 (FDA)
identified the drug’s solvent, diethylene glycol, as the killer.
Seventy-one adults and 34 children
died in 15 states in the fall (September
and October) of 1937 after taking a
drug called Elixir Sulfanilamide to treat a variety of ailments, from gonorrhea
to sore throat. At that time, the FDA, which had been launched in 1906 as the
Bureau of Chemistry, served simply to police claims made about food and drug
ingredients. No formal government approval was required to market new
drugs.
Categories:
Regulatory
General Concepts of the Ph.Eur
Categories:
Regulatory
Tuesday, October 27, 2015
Medicines - Life Saving Drugs
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Categories:
Pharmaceutical Science
Saturday, October 24, 2015
Creativity & Innovation
Categories:
General Articles
Friday, October 23, 2015
Thursday, October 22, 2015
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 Chinese pharmaceutical companies.
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Categories:
Industry News
QC Laboratory at a Glance
Categories:
QC Laboratory
Tuesday, October 20, 2015
Good and Bad Responses to 483s
Categories:
Regulatory
Sunday, October 18, 2015
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 promote public health and accelerate the growth and development of pharmaceutical sector.
Categories:
Industry News
Saturday, October 17, 2015
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
Categories:
Industry News
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 FDA’s Center for Biologics Evaluation and Research.
Categories:
Regulatory
Thursday, October 15, 2015
Good Laboratory Practice
Categories:
QC Laboratory
Wednesday, October 14, 2015
FDA's New Overseas Leaders
Categories:
Regulatory
Tuesday, October 13, 2015
Monday, October 12, 2015
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 popular weight loss drug, its popularity peaking in the 90’s. It is estimated that as many as 6.5 million people took it to help fight obesity. After consumers began experiencing heart disease and other pulmonary problems, the FDA set the recall in motion. American Lawyer reported that more than 50,000 Fen-Phen victims have filed suits against Fen-Phen’s maker Wyeth, and legal expenses combined with awards may have exceeded $21 billion. Lengthy time in the marketplace combined with the severity of both the public reaction and the significant awards granted to its victims make its impact unprecedented.
2) Diethylstilbestrol (DES)
- Maker: Multiple manufacturers (DES was never patented as it was created with British public funds)
- Recalled: 1975 (after 37 years on the market)
- Financial damage: Steep, but difficult to quantify because each manufacturer paid out legal damages correlated with its respective market share (a new way of awarding damages in these cases).
DES was prescribed for more than thirty years to prevent miscarriages and other complications during pregnancy. It was not until 1971 before it was connected to a rare tumor that kept appearing in the daughters of women who had taken it. The FDA only banned DES prescriptions to women because no such problems have been found in men. In fact, it can still be prescribed to men to treat estrogen deficiency. Litigation over DES led to a landmark products liability award that heavily influenced how both courts and the FDA approach oversight of drugs with multiple manufacturers.
3) Cerivastatin (Baycol)
- Maker: Bayer
- Recalled: 2001 (after four years on the market)
- Financial damage: Litigation-related damages totaled $1.2 billion
Baycol, prescribed to patients as a treatment for high cholesterol, is reportedly responsible for more than 100,000 deaths and about as many lawsuits. It was connected to a severe muscle disorder known as rhabdomyolysis, which clogs the kidneys with protein from dying muscle tissue.
4) Rofecoxib (Vioxx)
- Maker: Merck
- Recalled: 2004 (after five years on the market)
- Financial damage: nearly $6 billion in litigation-related expenses alone
Vioxx is considered to be the largest drug recall in history, and one which elicited one of the greatest public outcries. Vioxx, prescribed to more than 20 million people as a pain reliever for arthritis, was found to be responsible for increased risk of heart attack and stroke. Both Merck and the FDA were roundly criticized for ignoring evidence of the dangers of Vioxx before its eventual recall. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking the drug in the US alone. Merck settled Vioxx litigation in the US for $4.8 billion, with close to $1 billion in legal expenses.
5) Valdecoxib (Bextra)
- Maker: Pfizer
- Recalled in 2005 after just one year on the market.
- Financial damage: Over $2 billion in legal awards and expenses.
Bextra, like Vioxx, is a non-steroidal anti-inflammatory drug, that was prescribed to treat prescribed to treat arthritis and pain from other inflammatory disorders. It was removed from the market not long after Vioxx over similar concerns – increased risk of heart attack and stroke. In some cases, it was also found to cause a fatal skin condition. Although less publicized and the subject of fewer law suits, Bextra still resulted in $1.8 billion in legal awards against Pfizer and it’s subsidiary Pharamcia & UpJohn (not including expenses). The reason Bextra is on this list, however, is because it gave rise to one of the largest criminal fines ever imposed in the US. Pharmacia & UpJohn Company was fined $1.195 billion, in addition to legal awards, after admitting to criminal wrongdoing, specifically with ‘intent to defraud or mislead’ in relation to the promotion of the drug.
6) Troglitazone (Rezulin)
- Maker: Warner-Lambert
- Recalled: 2000 (after one year on the market)
- Financial damage: Warner-Lambert grossed $2.1 billion in sales before recall
The Rezulin saga, originally aired by the Los Angeles Times, was an ugly view into the process by which Rezulin was eventually removed from the market, but only after the FDA seemingly delayed the process due to complaints by Rezulin’s manufacturer. A FDA doctor who voiced concern over the drug was later removed from his position at the behest of Warner-Lambert, an action that delayed the recall process. Rezulin, an anti-diabetic and anti-inflammatory drug, was eventually found to be causally connected with hepatitis.
7) Able Laboratories Generic Prescription Drugs
- Maker: Able Laboratories
- Recalled: 2005
- Financial Damage: Able Laboratories had $103 million in annual sales before recall
On May 23, 2005, all of Able Laboratories’ products were removed from the market due to questions surrounding the quality of the manufacturing process. Some drugs were found to be too potent; others not potent enough. Moreover, four of its managers were found to have fraudulently distributed misbranded and adulterated drugs. The recall put Able Labs out of business.
8) Terfenadine (Seldane)
- Maker: Hoechst Marion Roussel (now Aventis)
- Recalled: 1997 (after 13 years on the market)
- Financial damage: Seldane was a big moneymaker for Hoechst Marion Roussel for such a long period (the year before it was pulled it sold $440 million worth of Terfenadine worldwide). In addition to its legal expenses, the loss of market share alone to drugs such as Loratadine (Claritin) was steep.
Seldane was a popular antihistamine brought to market in 1985 to treat allergies without causing drowsiness. The FDA sought a recall from the manufacturer after cases of cardiac arrhythmia (abnormal electrical activity in the heart) appeared in patients taking Seldane with other drugs. The recall is notable mostly for its scale; more than 100 million patients worldwide used Terfenandine as of 1990. Following Seldane’s recall, Hoechst was able to mitigate its damages to some degree by introducing Allegra, a drug very similar to Seldane but without its side effects.
9) Phenylpropanolamine (PPA)
- Maker: No principal manufacturer, widely manufactured across the industry
- Recalled: in 2000 (at least 60 years on the market)
- Financial damage: untold millions, if not billions (one manufacture alone settled for $15 million)
PPA, a psychoactive drug that saw many uses over its long history, is unique because it was never formally approved by the FDA. For decades it was used for everything from dieting to cold medication to treatment of psychological disorders, existing in a kind of limbo where it was neither banned nor fully endorsed. That is, until an analysis by Yale University in 2000 recognized its connection with cardiac events and stroke, particularly in women. The study estimated that 1 woman may have a stroke due to phenylpropanolamine for every 107,000 to 3,268,000 women who use products containing phenylpropanolamine as an appetite suppressant within a three-day window. The FDA estimates that between 200 to 500 strokes per year would have been prevented if PPA was replaced with something that presented less risks. More than 25,000 lawsuits have been filed against a variety of drug companies, and awards for damages across the pharmaceutical industry number in the hundreds of millions, if not billions.
10) Mibefradil (Posicor)
- Maker: Roche
- Recalled: 1998 (after one year on the market)
- Financial damage: Analysts had projected $2.9 billion in sales within 4 years
In only one year on the market, Posicor was linked to 123 deaths. Considered relatively safe when taken alone, Posicor became potentially deadly when combined with any of 25 different drugs. The large number of deaths are troublesome considering that the drug was prescribed to no more than 200,000 people worldwide in the space of one year, a relatively small number. Posicor is on this list for stimulating debate surrounding policies encouraging the FDA to hasten the approval of certain drugs. It is often cited as a strong example of what can go wrong when drugs are rushed to market.
Source :
http://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-of-the-fda/
Categories:
Regulatory
Sunday, October 11, 2015
Saturday, October 10, 2015
Q3D Elemental Impurities
Categories:
Regulatory
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 were distributed nationwide between July 2013 and August of this year. No adverse events have been reported, according to Merck.
In a similar incident, the FDA is alerting healthcare providers not to use compounded or repackaged drugs that have been stored in 3 ml and 5 ml syringes manufactured by Becton-Dickinson, unless there is no alternative. Drugs stored in these syringes may lose potency over time due to a possible interaction with the rubber stopper in the syringe, the agency says.
Providers who use a substitute product may need to adjust the dosage in case patients have been receiving a subpotent product to avoid adverse events, the agency adds.
Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA's interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.
Categories:
Industry News
Friday, October 9, 2015
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.
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http://www.fdanews.com/DID1007152?hittrk=DID15O1
Click below link :
http://www.fdanews.com/DID1007152?hittrk=DID15O1
Categories:
Industry News
Wednesday, October 7, 2015
Tuesday, October 6, 2015
Monday, October 5, 2015
Quality Metrics - FDA plan
Categories:
Regulatory
Clinical Trials - Research to Public Health
Click on the link to read :
https://drive.google.com/file/d/0BzX1tuvsApriU1hxN3BtdHdwRU0/view?usp=sharing
Categories:
Pharmaceutical Science
Sunday, October 4, 2015
Saturday, October 3, 2015
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 arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd. The drug, Elepsia XR, was its first to receive an FDA approval.
The company said in June it had been working "very aggressively" to find partners for the product. It had had "some advanced discussions" and aimed to launch the drug by the second half of fiscal 2016.
Analysts estimated modest sales of about $50 million annually from Elepsia XR.
SPARC had said it would produce the drug at Sun Pharma's Halol plant, in Gujarat, as an adjunct treatment for partial onset seizures in epilepsy patients of 12 years and older.
Most analysts saw the approval as positive mainly because it came despite the FDA having expressed concerns a year ago about manufacturing processes at the Halol plant.
Sun Pharma had been working on fixing the issues the FDA outlined and some analysts said the approval allayed fears of a possible adverse FDA action at Halol.
On Saturday, SPARC said the FDA issued it a "Complete Response Letter" in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval".
It said Sun Pharma "has taken several corrective measures" to fix problems at the plant.
Source : http://www.businesstoday.in/sectors/pharma/fda-revokes-approval-for-sun-pharma-seizure-drug-over-compliance-issues/story/224139.html
Categories:
Industry News
