Drugs
FDA has approved an expanded use for Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first therapy approved to treat the underlying cause of CF in this
Devices
FDA has approved magnetic resonance-conditional labeling for Envoy’s Esteem hearing implant, the only middle ear implant to receive approval for such labeling in both 1.5 and 3.0 Tesla scanning environments. The company says surgeons and audiologists who have worked closely with hearing implants have seen as
Drugs
FDA has issued a guidance, Elemental Impurities in Drug Products, with recommendations regarding the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of the International Council for Harmonization Q3D Elemental Impurities guidance. The document also is to assist manufacturers of compounded drug
Drugs
The Biotechnology Industry Organization (BIO) is asking FDA to clarify how its draft guidance on considerations for inclusion of adolescent patients in adult oncology clinical trials relates to provisions in the Pediatric Research Equity Act (PREA) and the FDA Reauthorization Act of 2017. The association’s comment letter says that
Devices
FDA has cleared a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue. “The SCOUT System has been in use for wire-free breast tumor localization since 2016 and has been proven in over 42,000 procedures in more than
Drugs
FDA has issued Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to the company, the letter said data submitted in the company’s NDA do not support the conclusion that the benefits of Remoxy outweigh the risks. “This is a bizarre
FDA Policy/General
Federal Register notice: FDA has announced an 11/5 public hearing on the future format of the National Drug Code (NDC). The agency is interested in stakeholder input on the impact of any future changes made to the length and format of the NDC. The hearing will be held at
Drugs
FDA has released a draft guidance entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” The document addresses the clinical endpoints acceptable to demonstrate the effectiveness of such drugs. For advice on specific drug development programs, sponsors are encouraged to contact CDER’s Division of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.” The document covers testing recommendations for these drugs, including electronic nicotine delivery systems intended for smoking cessation and other chronic uses. To view the notice, click here.
Drugs
FDA has granted Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer. The antibody-drug conjugate (ADC) uses a trastuzumab (Genentech’s Herceptin) variant form of an antibody. ALT-P7, which is being investigated for treating gastric and breast cancers, utilizes the company’s
Devices
FDA has cleared a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser. The accessory is indicated for use in conjunction with the laser to filter narrow band-UVB light at delivery in order to calculate and individualize the maximum
Drugs
FDA has granted Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant. The designation was based on efficacy and safety data from a Phase 2 single arm study in patients with hematologic malignancies who underwent a myeloablative
FDA Policy/General
Info Collection Extension Device Recall Authority Federal Register notice: FDA submits to OMB an information collection extension for “Medical Device Recall Authority” (OMB Control Number 0910-0432). 08/03/2018 Workshop on Advancing Pediatric Pharmacovigilance Federal Register notice: FDA announces a 9/14 public workshop entitled “Advancing the Development of
Drugs
FDA has approved an Indivior NDA for Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for treating schizophrenia in adults. Approval was based on data showing that clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental
Devices
FDA has released a guidance entitled: “Medical Device User Fee Small Business Qualification and Certification.” The document says that a business that is qualified and certified as a “small business” is eligible for a substantial reduction in most user fees. Application types eligible for reduced small business fee are: Premarket
Drugs
An FDA safety alert warns that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. “Results of a clinical trial found an increased rate
Drugs
FDA has granted PharmaMar an orphan drug designation for lurbinectedin and its use in treating small cell lung cancer. Lurbinectedin is described by the company as an inhibitor of RNA polymerase II, an enzyme that is essential for the transcription process that is over-activated in tumors with transcription addiction.
Drugs
FDA commissioner Scott Gottlieb says the agency is prioritizing its efforts to help product developers bring novel nicotine replacement therapy (NRT) drugs to market. “We know that about 70% of adult smokers in the U.S. want to quit,” he says in an online post. “In fact, nearly half try
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Device Recall Authority” (OMB Control Number 0910-0432). The information collection implements section 518(e) of the FD&C Act (21 U.S.C. 360h(e)) and part 810 (21 CFR part 810), mandatory medical
FDA Policy/General
Federal Register notice: FDA has announced a 9/14 public workshop entitled “Advancing the Development of Pediatric Therapeutics: Advancing Pediatric Pharmacovigilance.” The workshop is intended to gather information on the latest developments in pediatric pharmacovigilance from the perspective of various stakeholders and to expand the conversation to include the utility
FDA Policy/General
The Senate has passed a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacted level. The minibus (HR 6147) provides $2.97 billion in discretionary funding for the agency, which is about $150 million less than the House has approved
Drugs
Federal Register notice: FDA has announced that it has revoked an Emergency Use Authorization issued to Zalgen Labs for the ReEBOV Antigen Rapid Test, intended for use in detecting the Ebola virus. The authorization was revoked 5/18 as requested by the company in March after performance validation data were