FDA Policy/General
Federal Register notice: FDA is announcing the withdrawal of a 7/14/2011 proposed rule entitled “Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,” The agency is taking this action because the proposed changes are duplicative of a new FDA proposed rule that
FDA Policy/General
Federal Register notice: FDA is proposing to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federal Food, Drug, and Cosmetic Act resulting from enactment of the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act. The proposed rule
Devices
CDRH has published its three strategic priorities for 2022-2025. The document says the priorities are to promote a modern and diverse workplace, enhance organizational agility and resilience, and advance health equity. The report discusses progress made on the strategic priorities the Center set in 2018 and amplifies the three
Drugs
FDA has published a proposed rule, National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers, as required by the Drug Supply Chain Security Act. When finalized, the proposed rule would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription
Drugs
Four Hogan Lovells attorneys say an 11th Circuit Court of Appeals 1/28 mandate upholding orphan exclusivity for Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) “appears to undermine FDA’s indication-specific approach to orphan exclusivity, providing exclusivity holders (and those on deck for approval) potentially broader exclusivity than previously expected.” In
FDA Policy/General
FDA says that the most important enhancements in the Prescription Drug User Fee Act (PDUFA VII) reauthorization are a new early interaction meeting for getting feedback on development programs, a new program on drug supplemental submissions, and increased staffing to address the increasing review obligations of cell and gene therapy
Drugs
FDA has published a draft guidance, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format, to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products, specifically therapeutic protein products and of select drug products that have immunogenicity assessments. The
Drugs
Eli Lilly is delaying a planned BLA accelerated approval submission for its Alzheimer’s investigational antibody therapy donanemab due to uncertainties related to a Center for Medicare and Medicaid Services (CMS) decision (see earlier story) to propose restricting Medicare coverage of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). Lilly was
Drugs
The White House says President Joe Biden is reenergizing the Cancer Moonshot he launched in 2016 when he was vice president and setting ambitious new goals that he says will “end cancer as we know it today.” A White House online statement says the new goals are to: * cut today’
Drugs
FDA has published a draft guidance, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, with recommendations to industry on formal meetings between FDA and sponsors or requestors of nonprescription drugs without approved NDAs, known as over-the-counter (OTC) monograph drugs. The document specifies
Drugs
Two Hogan Lovells attorneys say companies operating in the telemedicine and electronic health records (EHR) spaces should expect increased False Claims Act (FCA) enforcement going forward and take steps to minimize their risk. The attorneys’ views are expressed in a white paper, “Healthcare Digitization Creates New FCA Risk.” “In recent
Drugs
FDA has approved a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for treating HIV-1 in virologically suppressed adults with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. Cabenuva was approved 1/2021
Drugs
FDA has placed a clinical hold on LogicBio Therapeutics’ Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia (MMA). According to the company, four patients have been dosed in the SUNRISE trial with LB-001, a single-administration, adeno-associated virus (AAV) genome editing
FDA Policy/General
FDA has named Kimberlee Trzeciak, the chief health advisor for the House Energy and Commerce Committee, as the agency’s associate commissioner for legislative affairs. Committee chairman Frank Pallone (D-NJ) praised the hire, saying Trzeciak was one of the committee’s first hires when he became ranking member in
Devices
FDA has cleared a Bone Solutions 510(k) for its Mg Osteorevive, a magnesium-based injectable and moldable bone void filler indicated for posterolateral spine fusion procedures. The company says that magnesium is a critical component for bone health and development, and plays a key role in the absorption and
Drugs
Jazz Pharmaceuticals has submitted a Supplemental BLA for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) and its use as a component of a multi-agent chemotherapeutic regimen for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one
Biologics
Pfizer/BioNTech reportedly have started submitting data to FDA to support an emergency use authorization for their Covid-19 vaccine for use in children aged six months to four years old. Bloomberg News reports it learned of the rolling submission of data from sources familiar with the situation. The news
Drugs
An FDA review of a Web site and Internet address maintained by Applied Health Solutions, Scottsdale, AZ, determined that the firm markets branded products that are considered to be drugs based on claims made for them at the Web site. A just-released 10/22/21 Warning Letter gives pages
Drugs
Medable, described as a patient-centered drug development cloud platform, says a Tufts Center for the Study of Drug Development analysis found that, on average, decentralized clinical trials are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase 2
Drugs
FDA has issued its 2021 Drug Safety Priorities report detailing CDER safety programs and activities and “highlighting the depth and versatility of drug safety initiatives across CDER and FDA.” The report is said to explain CDER’s efforts to manage drug safety through modernized safety surveillance methods and innovative responses
Drugs
Associations representing the innovative and generic drug industries say the U.S. should be using its trade policy to defend and protect American inventions. The Association for Accessible Medicines (AAM) and Pharmaceutical Research and Manufacturers of America (PhRMA) made the plea in comments to the United States Trade Representative on
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 29 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.