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19 Jan 2023, 11:47 am
Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. [read post]
8 Mar 2015, 9:41 pm
Noonan -- On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. [read post]
28 Dec 2009, 6:13 am
Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer. [read post]
19 Jan 2023, 11:47 am
Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. [read post]
23 Jun 2009, 9:54 pm
Food and Drug Administration in which Caraco sought to market a generic version of Prandin ®. [read post]
1 Aug 2022, 2:18 pm
The notice was specifically targeted to parties proceeding before both the USPTO and Food and Drug Administration (FDA) and was issued in response to urging by Senators to establish interagency communications aimed in part at eliminating so-called drug patent thickets. [read post]
1 Aug 2013, 10:00 am
., Board Certified by The Florida Bar in Health Law A California college student left in a small holding cell by the Drug Enforcement Administration (DEA) for five days without food, water, or a toilet has settled his claims for $4.1 million, according to a number of news sources. [read post]
25 Jan 2022, 4:15 am
§ 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. [read post]
25 Jan 2009, 9:59 pm
Food and Drug Administration has approved the biopharmaceutical company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. [read post]
11 May 2015, 8:45 pm
Food and Drug Administration issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act. [read post]
1 Aug 2013, 10:00 am
., Board Certified by The Florida Bar in Health Law A California college student left in a small holding cell by the Drug Enforcement Administration (DEA) for five days without food, water, or a toilet has settled his claims for $4.1 million, according to a number of news sources. [read post]
3 Oct 2024, 7:15 am
Senator Bill Cassidy (R-LA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to Robert Califf, Commissioner of the Food & Drug Administration (FDA), urging the agency to issue guidelines clarifying requirements for listing patents covering FDA-approved drugs in the agency’s Orange Book. [read post]
3 Oct 2024, 7:15 am
Senator Bill Cassidy (R-LA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter to Robert Califf, Commissioner of the Food & Drug Administration (FDA), urging the agency to issue guidelines clarifying requirements for listing patents covering FDA-approved drugs in the agency’s Orange Book. [read post]
23 May 2011, 2:59 am
Food and Drug Administration in formal warning letters.An April 13 warning letter to Star Food Products Inc., located in Weston, FL, alleged "serious violations" at the fish importer's facilities. [read post]
18 Feb 2015, 5:19 pm
Food and Drug Administration made an announcement that the drug may increase the risk of bladder cancer. [read post]
19 Sep 2013, 12:43 pm
Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. [read post]
17 Dec 2008, 9:34 am
Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). [read post]
31 Jul 2013, 11:18 am
Drug Enforcement Administration (DEA), his lawyers said on Tuesday.Daniel Chong, who was rounded up along with eight other people in an April 21, 2012, drug raid at a San Diego area home, has said that he was forced to drink his own urine and nearly died after being placed in the cell and apparently forgotten.After the ordeal, the 24-year-old student of the University of California, San Diego, spent five days in a San Diego hospital, three of them in intensive care. [read post]
29 Jul 2021, 1:54 am
Nursing home doctors have also been caught on relying heavily on the recommendation of nurses and other care staff when making these medication decisions.According to the Office of the Inspector General for the Department of Health and Human Services, more than half of atypical antipsychotic medications that affect at least 105,000 nursing home residents annually are being incorrectly paid for by Medicare, despite the drugs being deemed ineffective and potentially dangerous for the… [read post]
3 Apr 2015, 8:00 am
Lucas Richert has published Conservatism, Consumer Choice, and the Food and Drug Administration during the Reagan Era: A Prescription for Scandal (Lanham, MD: Lexington Books, 2014):In the last quarter of the 20th century, politicians in Washington, as well as interest groups, regulatory policy makers, and drug industry leaders were forced to confront the hot-button issue of pharmaceutical regulation. [read post]
