FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for MSD Italia’s Zejula (niraparib), indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The regulatory review period was
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0734). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for Newron Pharmaceuticals’ Xadago (safinamide mesylate), indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. The agency determined Xadago’s regulatory review period at 5,019 days, including 4,205 days that occurred
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Assessment of Combination Product Review Practices.” As part of the 2017 reauthorization of the Prescription Drug User Fee Act, FDA committed to contracting with an independent third party to assess current practices for combination drug product review,
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
FDA Policy/General
FDA Office of Chief Scientist critical path and regulatory science initiatives director Frank Weichold says that since 2012, the agency’s Centers for Regulatory Science and Innovation (CERSI) have grown from two to four Centers involving five universities and one nonprofit hospital. As of 12/2018, he says, the program
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
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