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
Drugs
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
Devices
FDA has granted Neurotech Pharmaceuticals a fast track designation for Renexus (NT-501) for treating macular telangiectasia type 2 (MacTel). Renexus is a cell-based drug delivery system. Human-derived cells encapsulated in a semipermeable hollow fiber membrane device release ciliary neurotrophic factor (CNTF), which is intended to reduce photoreceptor
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Investigational New Drug Application — 21 CFR Part 312” (OMB Control Number 0910-0014). To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: McKesson San Francisco, CA (2/7): FDA inspected the company 6/2018 which resulted in the first Warning Letter under the Drug
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
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Sarepta’s Duchenne drug Exondys 51 (eteplirsen) is 2,280 days, including 1,828 days that occurred during the testing phase and 452 days during the approval phase. To view the notice, click here.
Drugs
FDA has released a new plan to modernize dietary supplement regulation and oversight. It has been more than 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), and the regulated industry has exploded from 4,000 unique products to potentially more than 80,000 different products
Drugs
FDA’s Office of Criminal Investigations helped investigate a case where James Paul Adams (Cypress, TX), owner of One Source Healthcare Organization, agreed to pay the government $339,413 for allegedly accepting illegal kickback payments from OK Compounding. The government alleged OK Compounding paid substantial kickbacks to various third-party
FDA Policy/General
Federal Register notice: FDA has announced a 3/18 workshop entitled “Enhancing the Incorporation of Patient Perspectives on Clinical Trials,” which is being convened by the ongoing Clinical Trials Transformation Initiative. The workshop is seeking stakeholders’ perspectives on challenges and barriers to patients participating in clinical trials and best practices
Drugs
FDA has updated summary table forms (XXINSERT LINKXX) for ANDA submissions containing clinical endpoint studies. The previous version has been updated, and now includes two separate documents — one for submissions containing comparative clinical endpoint bioequivalence studies, and the other for submissions containing irritation/sensitization/adhesion studies (for transdermal and topical
Devices
FDA has granted BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury. The device is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than two
Drugs
FDA has issued 12 Warning Letters and five online advisory letters to foreign and domestic companies that are “illegally” selling more than 58 products, which include dietary supplements, that are unapproved or misbranded drugs because they are claiming to treat Alzheimer’s disease and other serious health conditions. The products,
FDA Policy/General
FDA Seeks Industry Reps to Serve on Advisory Committees Federal Register notice: FDA requests nominations for nonvoting industry representatives to serve on its public advisory committees for CDER. 02/08/2019 Info Collection Extension for Generic Drug Fee Coversheet Federal Register notice: FDA submits to OMB an information collection extension
FDA Policy/General
DEVICES FDA has cleared a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system. The device is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction, according to the company. In addition, the all-
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for CDER notify FDA in writing. The agency is also requesting direct individual nominations for nonvoting industry representatives to serve on CDER’s
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Generic Drug User Fee Coversheet” (OMB Control Number 0910-0727). To view the notice, click here.