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Would You Balk at Disclosing Confidential Information to Your Competitors?
…course, almost any document an ANDA applicant sends to FDA contains the application number. So it seems that the potential exists for almost any ANDA correspondence to become public. FDA…
IOM and Congress Press On to Expand Clinical Trials Data Sharing, Despite Ongoing NIH Rulemaking
…Institute of Medicine (“IOM”) released its report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks,” recommending an approach to clinical trial data sharing that parallels the clinical trial life…
Low Risk “General Wellness Products” Will Not be Regulated as Medical Devices
…promoted for medical uses. However, FDA will regulate the equipment and may require premarket notification if any promotional material appears which makes medical claims after marketing begins. When FDA issued…
First Look: NIH Proposed Rulemaking Would Expand Results Reporting to Unapproved Drugs and Devices, Defers on Expanding Other Types of Results Information
…non-technical and/or technical written summaries of the clinical trial, if these summaries can be included without being misleading or promotional. In order to make this determination, NIH would like to…
Latest Developments in the Amarin Litigation – Does Settlement Loom? And What Would it Mean?
…heels of losing the PI Motion, may believe it is likely to lose the case on the merits if the case proceeds to final judgment. Settlement may allow FDA to…
Invitation Accepted: PhRMA Sues HHS Over “Interpretive” 340B Orphan Drug Rule
…Affordable Care Act – which exempts orphan drugs from 340B pricing in cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals – applies only to orphan drugs…
Setting the Record Straight on GRAS: Part 2
By Ricardo Carvajal & Diane B. McColl – In Part 1 of our effort to characterize the principal errors and mischaracterizations underpinning attacks on the GRAS exception, we focused on…
Try Harder: The OIG Warns Drug Companies of Potential Liability for Medicare Beneficiaries’ Use of Copay Coupons, and Urges CMS to Work with Drug Companies and Other Stakeholders to Reduce Medicare Beneficiaries’ Use of These Coupons
…on the Medicare Part D program. The OIG also believes that drug companies have the ability to change the situation. Therefore, in the special advisory bulletin (SAB), the OIG cautions…
FDA’s Office of Generic Drugs Continues to Churn Out New and Revised Policies; Wants to Partner With Industry to Develop Best Practices
…that contain a Paragraph IV certification, but become eligible for approval during the review period as a result of no blocking patents or exclusivities (including 180-day exclusivity) and no applicable…
FDA Notifies Congress of Draft Guidance Documents Regarding Laboratory Developed Tests
…available. Similarly to “Traditional LDTs,” the guidance lists several factors FDA will consider when determining whether an LDT qualifies as being for an unmet medical need. One such factor is…
Senators Send Letter to OMB Requesting Release of LDT Draft Guidance
…are the standard of care. Starting in 1992, FDA stated that LDTs were medical devices but that it generally was exercising enforcement discretion. FDA announced in June 2010 that it…
TRICARE Announces Demonstration Program that Would Expand LDTs Eligible for Coverage During 3-Year Period and Possibly Beyond; Coalition Urges FDA to Create Single Framework for both Diagnostic Kits and LDTs
…and that the current dual system is arbitrary and capricious. Although the letter is framed in terms of equal treatment, since FDA is unlikely to deregulate in vitro diagnostic tests,…
DALVANCE Gains Bonus Exclusivity; FDA Grants the First Period of GAIN Act Exclusivity
…SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT),” that FDA created after the approval of NDA No. 204168 for FETZIMA (levomilnacipran) Extended-release Capsules, 20 mg, 40 mg,…
The Draft Guidance on Clinical Pharmacology Studies for Biosimilars – Is FDA Moving Forward, Sideways or Backwards by Retracing Steps Covered in the 2012 Draft Guidances?
…submitted. Sponsors are encouraged to collect data in the following order: structural and functional characterization, nonclinical evaluations, human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity studies, clinical safety studies and when…
Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances
…Procedure Act. The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) has also taken note of it, albeit without the flair and occasional snark our…