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…to value-based care and improve the coordination of patient care among providers and across care settings in the both the Federal health care programs and commercial sector.” A. Safe Harbors…
…final rule on intentional adulteration, entitled “Mitigation Strategies to Protect Food against Intentional Adulteration” (IA rule), 21 C.F.R. Part 121, was published in May 2016. The rule is designed to…
…cases, FDA did not make a formal forfeiture determination at the time of ANDA approval and stated it would do so only if another applicant becomes eligible for approval within…
…A complete agenda is available here. HPM attorneys will help present a half-day introduction to food law using a case-study approach that will cover (1) evaluating the regulatory status of…
…Group also recommends that the agency continue its ongoing effort to implement a unique device identification system, and consider using “real world” clinical data, such as data from electronic health…
…raising awareness, assisting with screening), patient groups should clearly characterize clinical studies as research, not misrepresent the investigational nature of the trial, and convey information about a trial as approved…
…has been known that carbadox was a carcinogen since before it was first approved in 1972. But, because FDA at that time believed that all carcinogenic residues from carbadox would…
…public health; and the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.” This categorization is independent…
…altered their devices, although FDA does not appear to be seeking feedback on this particular issue. Historical Background FDA has focused attention on these activities a number of times in…
…in the book this blogger authors – Generic and Innovator Drugs: A Guide to FDA Approval Requirements – exploring nearly all of the Orange Book minutiae you can imagine, the…
By James C. Shehan – In a citizen petition (Docket No. FDA-2015-P-4529) posted earlier this week, a group of fifteen institutional investors asked FDA to require that all approved prescription drug…
…marijuana from federal prosecution. Although a number of states have passed laws legalizing marijuana for medical or recreational use, federal law prohibits the possession, cultivation or distribution of marijuana and…
Join the Federal Bar Association (FBA) and its Federal Litigation Section on Tuesday, October 27 in Washington, DC for the Annual FBA Federal Litigation Conference! Expert panelists and judges will…
…Journal of the American Medical Association. According to Dr. Kesselheim, there is “little reliable evidence” that the TD PRV program has spurred novel drug development. “Several more promising approaches exist…
…of Qualifying Tropical Diseases On August 20, 2015, FDA published a final order to add two new diseases, Chagas disease and neurocysticercosis, to the list of qualifying tropical diseases. Recall…