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Federal District Court in Florida Delivers a Decisive Blow to FDA’s Authority to Regulate Pharmaceutical Compounding from Bulk Substances
…chastised the FDA for trying to “eradicate the line” between what would be considered unlawful manufacturing and the traditional compounding of animal medications. After engaging in a detailed historical, regulatory…
FDA Finalizes Authorized Generics Reporting Rule; Electronic Submissions Will be Permitted and Eventually Required
…of the information will no longer be required. Based on FDA’s historical review of annual reports, the Agency estimates that approximately 60 NDA sponsors will submit about 400 annual reports…
Revelations: FDA’s Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG
…enforcement action without prior notice,” and more specifically, that “prenatal vitamins are not excepted from this CPG.” FDA is apparently also taking a hard line on the post-September 19, 2011…
Striking the Right Balance – Comprehensive Addiction and Recovery Act of 2016
…the definition of a “line extension” that may be subject to higher rebates. CARA also amends the federal Controlled Substances Act to allow a pharmacist to partially fill a Schedule…
Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress
…preventing the parties from settling, it is likely that this bill will discourage generic drug companies from bringing challenges to brand companies’ patents in the first place—and as a result,…
Medical Device Recall or Product Enhancement? FDA’s New Draft Guidance Should Be Recalled for Significant Repairs
…a mere six sentences of very general advice (lines 219-236) and provides only three actual examples, all involving battery life (line 238). The draft guidance should have provided more examples,…
AMA Tells Pharmacists: “Don’t Call Us We’ll Call You”
…the patient, treats the patient, and determines the appropriate medical treatment. While pharmacists are responsible for guarding against fraudulent prescriptions and potential doctor-shopping patients, questioning the prescribing practices and medical…
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
…takes no position on whether it provided an explanation when it changed its position and gave final approval to Supplement 13. . . . That lack of opposition alone permits…
The Active Ingredient Stands Alone
…option would not have been available to InvaGen had the FDA instead determined that Somatuline Depot and InvaGen’s product were biological products.” Because FDA’s refusal to regulate Somatuline Depot as…
One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset Clause
…Disease Voucher program here and here. The Adding Ebola Act added Filoviruses, including Ebola, to the list of tropical diseases eligible for Tropical Disease Vouchers. It also brought several of…
Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently Awaited
…saying that Appellees are practicing revisionist history when it comes to MITIGARE’s approval, and that FDA ignores the clear statutory mandate about patent certifications. The bottom line in the case…
FTC Hammers POM Wonderful: Now On to the World Series
…concluded that the factual record lacked sufficient information to decide these issues. The Commission also left open the issue of the FTC’s authority to require FDA pre-approval for certain disease…
CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance Updates
…guidance is the addition of historical controls as an acceptable innovative trial design for regenerative medicine therapies. FDA clarifies that natural history data may provide the basis of a historical…
OIG Proposed Safe Harbor Revisions Take Aim at Formulary Rebates, Volume-Based PBM Administrative Fees
…reduction in price is provided to the dispensing pharmacy through a chargeback or series of chargebacks . . . .” Although this proposal is not crystal clear, the preamble describes…
Coming Soon for Expanded Access Policies
…obtain information about the outcome. The potential for poor outcomes in the expanded access setting and the potential for those outcomes to adversely affect the approval process has been cited…