Drugs
A 9/25-9/29/17 FDA inspection at Longwood Medicine (Beijing) Co., Beijing, China, found significant violations of current good manufacturing practices (CGMP) for finished pharmaceuticals. An 8/27 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and authority to
Drugs
FDA has posted a draft guidance entitled “Postapproval Changes to Drug Substances.” The document applies to synthetic drug substances and the synthetic steps involved in preparing semi-synthetic drug substances. It covers facility, scale, and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials,
Drugs
FDA has approved a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. The approval provides a new dosage strength (16mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and
Drugs
Members Sought for Mammography Quality Panel Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. 09/07/2018 Guide on Dietary Supplement Microbial Labeling Federal Register notice: FDA makes available a draft guidance entitled “Policy Regarding Quantitative Labeling of
Drugs
FDA has approved labeling revisions for three HIV drugs to include information on the risk of neural tube defects. The changes apply to ViiV’s Tivicay (dolutegravir), Triumeq (abacacir, dolutegravir, and lamivudine), and Juluca (dolutegravir, rilpivirine). In addition, weight gain was added to the Postmarketing Experience subsection of each label.
Drugs
A California federal court has dismissed on procedural grounds a suit brought by Pharmaceutical Research and Manufacturers of America (PhRMA) seeking to block enforcement of California Senate Bill 17 that imposed notification and reporting requirements on drug manufacturers for certain price increases on their products sold to state purchasers, insurers,
Drugs
FDA has denied, as “not appropriate at this time,” an International Probiotics Association 11/1/16 petition asking the agency to require that the quantitative amount of probiotic ingredients be declared in terms of colony forming units (CFUs). The denial letter notes issuance of a draft guidance explaining FDA’s
Drugs
FDA commissioner Scott Gottlieb says that as part of efforts under its 2018 Compounding Policy Priorities Plan, it has revised a draft memorandum of understanding (MOU) between FDA and states. He says the revised MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. “Today’s
Drugs
FDA has scheduled a 10/19 public meeting on “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC). A notice says the session is intended to provide members of the pharmaceutical industry and interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues
Drugs
FDA has approved Teva’s Cassipa (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence. An agency statement says the approval provides a new 16 mg/4 mg dosage strength of buprenorphine and naloxone sublingual film. The drug was approved through the 505(b)(2) abbreviated approval pathway
Drugs
Beaumont Bio Med has recalled its entire aqueous/alcohol-based product line due to possible microbial contamination. All products are manufactured by contract manufacturer King Bio. “The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result
Drugs
FDA has issued a draft guidance, Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials, to advise firms that manufacture, market, or distribute dietary supplements of the agency’s intent to exercise enforcement discretion about the declaration of live microbial quantity in colony forming units (CFUs) in addition to
Drugs
A 7/11-7/22/16 FDA inspection at Advanced Pharma, Houston, TX, a drug outsourcing facility now owned by Avella Specialty Pharmacy, found that drugs that violate the Federal Food, Drug, and Cosmetic Act were produced in the facility. An 8/14 Notice of Violation lists these issues: * failing
Drugs
CDER has published a Manual of Policies and Procedures. Good Review Practice: Refuse to File, outlining the policies, responsibilities, and procedures for the Office of New Drugs to follow to determine whether there is a basis to refuse to file (RTF) an NDA, sNDA, BLA, or sBLA submitted to CDER.
Drugs
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram told the Association for Accessible Medicine’s GRx+Biosims 8/5 meeting that FDA is making significant progress in carrying out its Drug Competition Action Plan and Biosimilars Action Plan. She reviewed actions taken under each program and also
Drugs
FDA has published guidances to assist sponsors in developing products to treat allergic and nonallergic rhinitis. Allergic Rhinitis: Developing Drug Products for Treatment addresses issues of trial design, effectiveness, and safety for new products being developed to treat seasonal allergic rhinitis and perennial allergic rhinitis. The document says its recommendations
Drugs
CDER has issued a Manual of Policies and Procedures for the site selection model (SSM) used by Center staff to prioritize manufacturing sites for routine CGMP surveillance inspections. The document says the Center implemented a risk-based approach to prioritizing human drug manufacturing sites for routine CGMP surveillance inspection in
Drugs
A new analysis commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that about one in five hospitals marks up medicine prices 700% or more. The analysis is presumably intended to deflect criticism of the pharmaceutical industry for unnecessarily raising drug prices and thus burdening U.S. health
Drugs
The International Contrast Ultrasound Society (ICUS) is asking FDA to remove Boxed Warnings from ultrasound contrast agent (UCA) labels “in order to bring the labeling into line with the current body of scientific research, which now clearly demonstrates the favorable safety profile and clinical benefits of these radiation-free diagnostic
Drugs
FDA has granted Pfizer a breakthrough therapy designation for its investigational oral Janus kinase 3 inhibitor PF-06651600 for treating patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body. The designation was supported by positive results from a Phase 2
Drugs
FDA has accepted for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The submission is based on data from the Phase 2 KEYNOTE-017 trial that evaluated the overall response rate
Drugs
Pfizer says it has publicly urged manufacturers of Biosimilar User Fee Act products not to be solely focused on similarity when meeting with FDA. It has said that sponsors should be discussing manufacturing, packaging, and filing questions with the agency as they would for any biological product. “This should be