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https://www.fda.gov/consumers/consumer-updates/fda-101-how-use-consumer-complaint-system-and-medwatch
If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it. FDA offers a number of ways to report a complaint. Two of the main ...
https://www.accessdata.fda.gov/scripts/cder/daf/
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
https://www.washingtonpost.com/business/economy/investigation-of-generic-cartel-expands-to-300-drugs/2018/12/09/fb900e80-f708-11e8-863c-9e2f864d47e7_story.html
Dec 09, 2018 · When the FDA grants approval for a generic product, the first company in the door gets six months of exclusive rights to market the drug. The price discount from the brand-name product is ...
https://www.nytimes.com/2018/05/17/health/drug-prices-generics-fda.html
May 17, 2018 · The Federal Trade Commission has also been investigating the practice. Some brand-name drug makers say the legislation is not needed. The F.D.A. has been speeding up approval of generic drugs, and ...
https://www.washingtonpost.com/business/economy/states-allege-generic-drug-executives-deleted-texts-obstructed-justice-in-price-cartel-probe/2019/05/10/450c6b30-7355-11e9-9eb4-0828f5389013_story.html
May 10, 2019 · States allege generic drug executives deleted texts, obstructed justice in price cartel probe ... state attorneys general alleged Friday in a civil complaint. ... Generic drugs make up about 90 ...
http://www.marylandattorneygeneral.gov/news%20documents/genericdrugsexpandedcomplaint.pdf
Generic Drugs – Expanded Complaint October 31, 2017 ... market, generic drugs should be less expensive and less prone to dramatic price spikes – this is ... were due to benign factors like industry consolidation, FDA-mandated plant closures or elimination of unprofitable generic drug product lines.
https://www.cbsnews.com/news/generic-drug-lawsuit-massive-fraud-an-attack-on-the-american-people-connecticut-attorney-general-says/
May 13, 2019 · 43 states and Puerto Rico filed a complaint Friday alleging 20 companies coordinated to inflate prices and reduce competition on more than 100 generic prescription drugs
https://www.nytimes.com/2019/05/11/health/teva-price-fixing-lawsuit.html
May 11, 2019 · The bulk of the collusive activity occurred from July 2013 to January 2015, according to the complaint, when Teva raised prices on nearly 400 formulations of 112 generic drugs.
https://www.biopharmadive.com/news/celgene-johnson-fda-anticompetitive-generic-list/523871/
May 18, 2018 · Celgene, Novartis and Gilead Sciences are among several dozen drugmakers called out by the Food and Drug Administration on Thursday for potentially impeding generic competition by blocking access to samples of their drugs. The FDA, in one of its more forceful steps to curb what it terms "gaming tactics" by pharma companies, published a list of ...
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=glossary.page
Drugs@FDA Frequently Asked Questions (FAQ) Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
https://www.drugs.com/availability/generic-ritalin.html
By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. AB: Products meeting necessary bioequivalence requirements.7.4/10
https://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/
Oct 10, 2012 · The FDA has long been a strong proponent of generic drugs, and generics have saved consumers and the federal government billions of dollars vs. brand-name drugs.Author: David Maris
https://www.ftc.gov/news-events/press-releases/2016/03/ftc-sues-endo-pharmaceuticals-inc-others-illegally-blocking-lower
The Federal Trade Commission filed a complaint in federal district court alleging that Endo Pharmaceuticals Inc. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Opana ER and Lidoderm.
https://www.bloomberg.com/news/articles/2017-06-26/what-you-don-t-know-about-generic-drugs-and-how-it-can-hurt-you
Jun 26, 2017 · What You Don’t Know About Generic Drugs, and How It Can Hurt You By . Anna Edney. What You Don’t Know About Generic Drugs, and How It …
https://nastlaw.com/generic-drug-price-fixing-lawsuit/
As more generic manufacturers enter the market for a particular drug, prices are pushed lower, usually settling at around 20% of the brand drug price. Since the early part of this decade, however, the prices of some generic drugs have risen alarmingly. For some drugs prices have skyrocketed.
http://www.fdalawblog.net/wp-content/uploads/2018/10/RESTASIS-Teva-Complaint.pdf
Hatch-Waxman sought to remove those barriers, increase the availability of generic drugs, and reduce prescription drug costs. Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1326 (D.C. Cir. 1998). 14. To do so, it authorizes FDA to approve a generic version of a previously-approved drug so long as the proposed generic drug is “the same as” a
https://www.ftc.gov/news-events/press-releases/2020/02/ftc-fda-sign-joint-statement-promoting-competition-markets
Submit a Consumer Complaint to the FTC; Apply for a Refund in an FTC Case ... as they are often far more complex to develop than other drugs,” said FDA Commissioner Stephen M. Hahn, M.D. “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics ...
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