Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP), Acceptability of Standards from Alternative Compendia (BP/EP/JP), to clarify for reviewers the appropriate use of quality standards for excipients, drug substances, and drug products found in the British, European, and Japanese pharmacopeias. The
Drugs
FDA has approved an Adapt Pharma NDA for Narcan (naloxone) Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression. Last year, the agency approved Narcan Nasal Spray 4mg under the expedited review and approval
Drugs
FDA and U.S. Pharmacopeial Convention have announced a 2/27-28 workshop on “Standards for Pharmaceutical Products — Critical Importance of Excipients in Product Development.” Attendees will discuss how the quality and variability of excipients currently impact medicines and how they are expected to impact new technologies such as continuous
Devices
FDA has cleared a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems. When used with the company’s Confidence High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors, the company says. The
Drugs
The CDER Small Business and Industry Assistance (SBIA) program says that changes included in the GDUFA 2 agreement now awaiting congressional action address small business concerns that arose under GDUFA 1. In an online SBIA Chronicles, CDER Division of User Fee Management and Budget Formulation generics branch chief Gisa Perez
FDA Policy/General
FDA has cleared a Gramercy Extremity Orthopedics (GEO) 510(k) for the GEO Bone Screw System, which can be used for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachments. The device offers a variety of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. The company says
Drugs
Advera Health Analytics has issued an evidence review on comparative safety of six HER2 antagonists indicated for treating breast and stomach cancers. The report (registration required) shows that based on FDA adverse event reporting data, Genentech’s Kadcyla (ado-trastuzumab emtansine) and Genentech’s Perjeta (pertuzumab) have multiple unlabeled adverse
Devices
An FDA-funded study reported in the New England Journal of Medicine says that a strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular closure device. Initial reports occurred within the first 12 months of monitoring, the report says.
Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures, Product Quality Microbiology Information in the Common Technical Document—Quality (CTD-Q), to assist CDER product quality microbiology reviewers by providing the expected locations of product quality microbiology information in the CTD-Q format. The document
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says that FDA is receiving orphan drug designation requests at a record rate of 1.6 per day, up from 2.23 per work day in 2016, and is granting designation requests at a near-record rate of 0.9 per day, down
Drugs
Hospira has recalled one lot of vancomycin hydrochloride for injection due to a confirmed customer report of particulate matter within a single vial. “In the unlikely event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood
Biologics
CBER has posted eligibility criteria for qualifying a product as a “regenerative advanced therapy” (RAT) and an accelerated approval pathway as mandated by the 21st Century Cures Act, which was signed into law last month. According to the Center, a product can be eligible for this pathway if: * The drug
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Actemra (tocilizumab) for treating giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The submission is based on “positive outcome” data from a Phase 3 called GiACTA that evaluated Actemra in people with GCA, according to the
Drugs
The Federal Trade Commission has filed a federal court stipulated order resolving charges that Endo Pharmaceuticals and Endo International violated antitrust laws by using so-called pay-for-delay settlements to block consumer access to generic versions of its Lidoderm topical patch indicated to relieve post-herpetic neuralgia and Opana
Drugs
FDA plans to request data on pharmaceutical quality metrics and has proposed guidance on data collection and submission, according to the Deloitte Life Sciences Regulatory Outlook for 2017. The document says the proposed guidance would change how FDA schedules its inspections, helping to promote modernization of the drug industry and
Drugs
The Justice Department says that Baxter Healthcare Corp. has agreed to pay $18.158 million to resolve criminal and civil liability arising from its failure to follow current good manufacturing practice (cGMP) when manufacturing sterile drug products in North Carolina. A department statement says the resolution includes a deferred prosecution
Biologics
FDA has posted a response to three citizen petitions that offered recommendations on biosimilar nonproprietary naming policies culminating in its final guidance on Nonproprietary Naming of Biological Products, which requires biological products to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under
Drugs
Hogan Lovells attorneys say that one of the features of the 21st Century Cures Act is an attempt to bring consistency and efficiency to the regulation of combination products. In an online blog post, the firm says that the new law brings two important clarifications to the process of determining
Drugs
Novartis says that its generic version of Amgen’s Enbrel (etanercept) will not go on sale until 2018 at the earliest due to Amgen’s patent protection challenge. FDA has approved Novartis’ biosimilar Erelzi (etanercept-szzs) with an indication for rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, and other diseases. Amgen
Drugs
FDA has released an FDA-483 issued following a 12/5-12/9/16 inspection at Granules Omnichem Private Limited, Visakhapatnarn, India. The document lists these deviations from current good manufacturing practice regulations for active pharmaceutical ingredients: * failure of the quality unit to ensure review of all deviations reported during
Devices
FDA has approved a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system. “With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices
Drugs
FDA has issued Natco Pharma Ltd. a six-item Form 483 after a 1/16-24 inspection of its pharmaceutical formulations facility in Kothur, near Hyderabad, India. In an unprecedented move by the company, it released a redacted copy of the inspection report. The company says the observations are “correctable,