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The End* of a Long and Winding Road: FDA Publishes Final LDT Rule (*Or Is It?)
…at war with Eurasia” in 1984.) LDTs are Illegal. Almost as disturbing as FDA’s revised history is its bald statements that LDTs are, and always have been, illegal. FDA states,…
FTC Issues FY 2012 Patent Settlement Report; Says a Record Number of Agreements Filed With “Pay-for-Delay” Potential
…slated to hear Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), a drug patent settlement agreement case involving ANDROGEL (testosterone gel) (see our previous post here). The case…
“Carcinogen-Free” Label Program Proposed in House Bill
…the estimated revenue for all “Carcinogen-Free” label application fees would be equal to the estimated cost of running the program. The bill also calls for random testing of products for…
FDA Seeks Comments on Custom Devices
…commercial distribution”; “[I]s designed to treat a unique pathology or physiological condition that no other device is domestically available to treat”; Is intended to meet the special needs of a…
GAO Report: FDA’s Food Recall Process Needs Strengthening
…and meeting the needs of diverse public audiences. For example, a delay in communication can result in more illnesses and deaths, but a premature communication can trigger major financial losses…
Massachusetts Relaxes Laws on the Offering of Prescription Drug Coupons and Meals to Health Care Practitioners
…coupons for prescription drug and biological products, and (2) the marketing laws to allow prescription drug and medical device manufacturers to provide meals to health care practitioners (HCPs) consumed outside…
FDA Approves Class-Wide Opioid REMS After More Than Three Years
…therapy in the following categories: assessing patients for treatment; initiating therapy, modifying dosing, and discontinuing use; managing therapy; counseling patients and caregivers about safe use; general drug information about ER/LA…
FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges that FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure
…or because the sponsor of the first approved product either cannot assure the availability of sufficient quantities of the drug or consents to the approval of other applications. For several…
FDA Publishes Second Annual Reportable Food Registry Report
By Ricardo Carvajal — FDA’s second annual reportable food registry (RFR) report confirms that foodborne pathogens and undeclared allergens continue to account for the vast majority of instances of reportable food. …
FDA Issues Draft MDUFA Performance Goals and Procedures
…this goal will encourage FDA to do a very thorough review of the submission and consider all factors before sending the letter. Managers should carefully review proposed additional deficiency letters…
A Trio of Reports Discuss the Benefits of the Pediatric “Carrot and Stick” Statutes, the Orphan Drug Act, and Hatch-Waxman
…by the IOM reached several broad conclusions detailed in the report: Pediatric studies conducted under BPCA and PREA are yielding important information to guide clinical care for children. Information from…
FDA Law Blog Turns the Ripe Old Age of 5!
…plan on slowing down. In fact, we’ve heard from several seniors (real ones) that they are busier in old age than ever. Old age has its benefits too – and…
GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and Misuse
…extended-release and long-acting pain relievers. NIH communicates with prescribers at medical conferences while SAMHSA developed a CME course on prescribing opioids for chronic pain, partnering with local organizations such medical…
What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers
…and benefits of participating in a gene therapy clinical trial How the FDA works to ensure that gene therapy clinical trials are as safe as possible for patients Gene therapy…