Drugs
FDA has released a draft guidance on “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.” A drug master file (DMF) is a voluntary submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing one or more human
Drugs
FDA has released a fact sheet to explain its “Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.” The sheet provides an abbreviated overview of the guidance and pilot program. The pilot is intended to take advantage of the growing acceptance of consensus standards in medical device reviews. It
Drugs
Allergan and its Forest Laboratories subsidiaries have settled for $750 million a lawsuit brought by direct purchasers of Alzheimer’s drug Namenda (memantine) that alleged Forest illegally delayed generic competition. The settlement does not recognize any wrongdoing and resolves litigation that was scheduled to go to trial this week. Plaintiffs
FDA Policy/General
Orthopedic Surgical Instruments Put Into Class 2 Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). 10/25/2019 Draft Guide on Homeopathic Drug Products Federal Register notice: FDA makes available a revised draft guidance entitled “Drug Products
FDA Policy/General
Patricia Industries has acquired Toronto, Canada-based medical device company Laborie from Audax Private Equity. Laborie develops technology for the diagnosis and treatment of urologic and gastrointestinal disorders. Its sales were $117 million in fiscal year 2018. Pfizer has agreed to buy San Francisco biotech Medivation for about $14 billion.
Drugs
FDA has approved a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria. Approval was based on data from a Phase 3 study that compared Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary
Drugs
FDA has authorized NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for patients with previously untreated locally advanced or metastatic biliary tract cancer. The 828-patient study will randomize patients to receive either a combination of Acelarin plus cisplatin or
FDA Policy/General
Federal Register notice: FDA has classified orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (special controls). This action was in response to a 1/2018 request from Cartiva Inc. for accessory classification of its reusable implantation instruments for the Cartiva Synthetic Cartilage Implant. Such
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Drug Products Labeled as Homeopathic.” The document describes how FDA intends to prioritize enforcement and regulatory action on homeopathic products marketed without approval that potentially pose a risk to public health. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing the NDA approval of Allergan Pharmaceuticals’ Lo Minastrin FE (ethinyl estradiol tablets, 0.01 mg; ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg). Allergan notified the agency that the drug product was no longer marketed and
FDA Policy/General
Federal Register notice: FDA has classified internal therapeutic massagers into Class 2 (special controls). This action is based on an 8/20 National Center for Pelvic Pain Research Devices request for De Novo classification of the AHIP Internal Trigger Point Wand. Such devices are identified as hand-held prescription devices
Devices
FDA is growing concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to their use. “The recent closure of a Sterigenics ethylene oxide sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure
Devices
Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump. “Nearly two years of real-world outcomes data on Abiomed’s Impella RP heart pump shows that when physicians followed the FDA’s approved protocol for Impella RP use
FDA Policy/General
Federal Register notice: FDA has announced its decision to exempt a list of Class 2 devices from premarket notification requirements. Comments are being accepted until 12/24 on the exempt devices. They are: * Accessory, Assisted Reproduction (product code MQG): Exemption is limited to assisted reproduction laminar flow workstations * Media, Reproductive
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.” The guidance revises a 2011 document to describe the multiple factors that the agency considers before requiring a postmarketing study
FDA Policy/General
Federal Register notice: FDA is making available a publication containing modifications the agency is making to the list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The listing, “Modifications to the List of Recognized Standards, Recognition List Number: 052” is intended to assist manufacturers who
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Breast Implants — Certain Labeling Recommendations to Improve Patient Communication.” The document contains recommendations about the content and format for certain labeling information for saline- and silicone gel-filled breast implants. To view the notice, click here.
Drugs
Harvard Medical School researchers say that publicly supported research was central to the development of at least 25% of all new drugs approved by FDA between 2008 and 2017. Writing in the BMJ, the researchers say that the public support came either through direct contributions to drug development or through
Drugs
FDA acting commissioner Ned Sharpless says one of the agency’s focuses in 2019 has been to implement the Substance Use-Disorder that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) that passed 10/24/18. The bill gave the agency new authorities to advance efforts
Drugs
FDA says it is releasing a second liquid chromatography-mass spectrometry method for use in detecting and quantifying NDMA in ranitidine. The agency also announced two ranitidine recalls. An agency statement says FDA is using the new method to test potential NDMA-containing ranitidine samples. The method uses a more
Drugs
FDA acting commissioner Ned Sharpless and CDER director Janet Woodcock say the agency has taken steps to clarify its risk-based enforcement approach to drug products labeled as homeopathic. In a statement, Sharpless and Woodcock say FDA has revised its 2017 draft guidance to give additional information on the risk-
Drugs
FDA has approved an Allergan supplemental BLA for Botox in treating pediatric patients (two to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs,