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Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…for the Office of Colors and Cosmetics (OCAC). Funding provided for OCAC is for direct support of the operation, staffing, compliance, research and international activities performed by this office. The…
As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
…of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…personnel of the Centers; Enhancement of interactions of the Centers with patients, sponsors, and the external biomedical community; and Facilitation of collaborative relationships of the Centers with other HHS agencies….
Proposed Changes to the Device Intended Use Regulation
…an ecosystem for the evaluation of device performance, both on label and off‑label, in order to make appropriate use of the technology. FDA’s evaluation (or lack thereof) certainly plays an…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…delayed the availability of accurate and reliable tests. The adverse consequences of FDA regulation of LDTs in the time of a pandemic was foreseeable. This is not a case of…
Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution
…Treatment of profuse watery diarrhea associated with VIPoma. 11/25/1998 (11/25/2005) ofatumumab (Arzerra) Treatment of chronic lymphocytic leukemia (3/10/2009) Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients…
A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion
…approval today of these communications is based on the present record. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain…
What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19
…of laboratory tests developed by high-complexity laboratories in lieu of an EUA. Prior to publication of this guidance, on March 12, FDA issued enforcement discretion for laboratory tests authorized by…
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
…covers the full costs associated with the product. Any recovery by the applicant of all or part of the costs of manufacture or distribution of a product makes the distribution…
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…provision; The average time for completion of review under this provision; The average time for completion of review of supplemental applications where FDA did not use this review flexibility; and…
FDA Proposes to Clarify and Update Orphan Drug Regulations
…obtained orphan exclusive approval of the drug for only a subset of the orphan disease or condition for which the drug was designated subsequently obtains approval of the drug for…
The Shutdown: An Update on FDA Activities
…Agency) seems to have been the state of affairs for several days last week. What’s on and what’s off for FDA has been an ongoing topic of discussion since before…
PTE Countdown (Or Not?!?): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (Read to a Funky Soundtrack and Vocals by The Pointer Sisters)
…submission to the date of FDA’s approval of an NDA. A patent term may be extended for a period of time that is the sum of one-half of the time…
FDA Issues Letter Decision on Generic SUBOXONE 180-Day Exclusivity; It’s a Doozy!
For those of us in the Hatch-Waxman Community, June 14, 2018 sowed a lot of confusion. That’s the date on which FDA approved three ANDAs for generic versions of Indivior…
Deliverance: FDA is Sued Over the Applicability of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs; Agency Gets a Short Reprieve to Make a Final Decision
…Earlier this week, Veloxis filed a Complaint and a Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s denial of approval of the…