Drugs
CDER is soliciting applications for an Established Conditions pilot program to propose explicit established conditions (ECs) as part of an NDA, ANDA, BLA, or prior approval supplement to any of those three. A Federal Register notice says the concept of ECs was first described in a 5/2015 FDA draft
Drugs
FDA has issued Motif Bio a complete response letter on its NDA for iclaprim for treating acute bacterial skin and skin structure infections. The letter indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved, according to the company. Motif
Drugs
Public Citizen says that unless an FDA proposed rule on institutional review board (IRB) waiver or alteration of informed consent for minimal risk clinical investigations is clarified, it could increase the risks to human subjects while undermining their right to informed consent before being enrolled in clinical trials. The group’
Drugs
FDA is permitting marketing of Tandem Diabetes Care’s t:Slim X2 insulin pump with interoperable technology for delivering insulin under the skin for children and adults with diabetes. An agency announcement says this new type of pump, an alternate controller enabled (ACE) infusion pump, is the first interoperable pump,
Drugs
Sen. Edward Markey (D-MA) and Rep. Diana DeGette (D-CO) have written to FDA commissioner Scott Gottlieb expressing their concern with agency approval of AcelRx’ Dsuvia (sufentanil sublingual tablets) that they say is 10 times more potent than fentanyl and 1,000 times more powerful than morphine. “While we
Drugs
In what many are calling a breakthrough treatment for depression, Janssen Pharmaceutical has moved one step closer to FDA approval after the agency’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee 2/12 jointly voted 14 to 2 to support Spravato (esketamine) nasal spray. The
Drugs
House Energy and Commerce Committee leaders have sent a letter to FDA commissioner Scott Gottlieb requesting a briefing on numerous recalls involving drugs manufactured overseas that may have been contaminated with trace amounts of known carcinogens, which could lead to a shortage of drugs to treat high blood pressure (see
Drugs
A 1/24-2/9/18 FDA inspection at Samson Pharmaceuticals’ drug manufacturing facility in Commerce, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/13/18 Warning Letter says the violations were: * failing to perform aseptic processing operations within specifically
Drugs
A 4/9-5/16/18 FDA inspection at the Akorn drug manufacturing facility in Decatur, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/4 Warning Letter says specific violations were: * failing to follow appropriate written procedures designed to prevent
Drugs
FDA has released the FDA-483 with 13 observations issued following an 8/6-8/14/18 inspection at Immunomedics, a Morris Plains, NJ, drug substance intermediate manufacturing facility. Specific observations were: * the quality unit lacks authority to investigate critical deviations of approved procedures, specifically involving a 2/2018 data
Drugs
FDA has released a draft guidance, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, describing a proposed program to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. “CDER is issuing this guidance to obtain public comments on
Drugs
FDA has released the FDA-483 issued following a 1/17-1/25 inspection at Indoco Remedies Limited (Plant 1), a Goa, India, tablet manufacturer. The six inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Drugs
FDA commissioner Scott Gottlieb says the agency has issued its first Warning Letter under the Drug Supply Chain Security Act, citing McKesson Corp. for violations highlighted by a “concerning tampering incident that involved opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder, and high
Drugs
Allergan says it “applauds FDA’s efforts to articulate thoughtful and science-driven guidelines” relating to development of biosimilar products. In a 2/11 comment letter on an FDA revised draft Q&As on biosimilar development and the Biologics Price Competition and Innovation Act, the company says the agency’
Drugs
Parexel says it has appointed four former FDA executives to its regulatory consulting group. Joining the team that helps client companies understand and work within current FDA and global regulatory climates to optimize drug development and mitigate risk of unnecessary delays are Kurt Borson (CDER, specializing in viral safety of
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA recognition of the potential of digital health and supports agency efforts to provide clarity about its approach to regulating software associated with prescription drug products. In a comment on the agency’s proposed framework for prescription drug-use-related
Drugs
FDA has released the FDA-483 issued following a 1/14-1/25 inspection at Lupin Limited, a Madhya Pradesh, India, drug manufacturer. Specific inspection observations listed on the form were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to
Drugs
The World Health Organization (WHO) has issued a medical product alert confirming that “falsified” versions of Takeda/Incyte’s leukemia drug Iclusig (ponatinib HCl) 15 mg and 45 mg are circulating in the WHO region of Europe and WHO region of the Americas. The alert says WHO was informed by
Drugs
CDER Office of Study Integrity and Surveillance (OSIS) deputy director Sally Choe has been selected as permanent director of the Office of Generic Drugs, replacing Kathleen Uhl who is departing at the end of the month. Choe is a recognized expert in drug review, clinical pharmacology, biopharmaceutics, and pharmacokinetics, according
Drugs
FDA has cleared a LaserOptek 510(k) for its PicoLO picosecond Nd:YAG for use in dermatology and general and plastic surgery. The device generates “high peak power and consistent picosecond pulse duration” to quickly and effectively breakdown and fragment pigments such as those found in tattoos, the company says.
Drugs
FDA has granted Amplyx Pharmaceuticals an orphan drug designation for APX001 and its use for treating cryptococcosis. The therapy has previously received an orphan drug designation for treating invasive candidiasis, invasive aspergillosis, coccidioidomycosis, and rare mold infections caused by Scedosporium spp., Fusarium spp., and Mucorales fungi (including Mucor spp., and
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The submission is