Drugs
FDA has issued a guidance, Regulatory Classification of Pharmaceutical Co-Crystals, to give applicants planning to submit NDAs and ANDAs information on the appropriate regulatory classification of pharmaceutical co-crystal forms. The guidance includes information about the data that applicants should submit to support the appropriate classification of a co-
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA draft guidance on refusal to file NDA and BLA submissions to CDER will help manufacturers prepare complete applications that are ready for filing, reducing burdens on industry and the agency both. But it also says that some aspects
FDA Policy/General
Federal Register notice: FDA has announced a 3/19 workshop on “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” The workshop’s goal is to discuss with stakeholders the development and regulatory decision-making challenges for such products. It will also address promising study designs and analytical
FDA Policy/General
FDA principal deputy commissioner Rachel Sherman says the agency doesn’t do well at developing experienced successors to key leaders who are approaching retirement. “It’s not our strongest suit, to be perfectly honest,” she said at the BIO CEO & Investor Conference 2/13. “We’re getting old,” Sherman
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy (castration-resistant). An agency release says that this is the first approved treatment for non-metastatic, castration-resistant prostate cancer.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Warner-Lambert’s Ibrance (palbociclib) is 3,954 days. Of this time, 3,779 days occurred during the testing phase and 175 days during the approval phase. Ibrance is indicated for treating of hormone
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Boehringer Ingelheim’s Jardiance (empagliflozin) is 2,275 days. Of this time, 1,760 days occurred during the testing phase and 515 days during the approval phase. Jardiance is indicated as an adjunct to
Drugs
Merck says it is ending its APECS Phase 3 study evaluating verubecesat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme, in people with prodromal Alzheimer’s disease. The company says its decision to end the study follows an external data monitoring committee evaluation that
Drugs
The National Institute of Allergy and Infectious Diseases says it is sponsoring a clinical trial to determine whether low blood levels of the protein procalcitonin (PCT) can reliably indicate whether a person’s lower respiratory tract infection will improve with antibiotic treatment. The agency says that healthcare providers often prescribe
Drugs
A 1/12-1/20/17 FDA inspection at the Bayer Pharma AG drug manufacturing facility in Leverkusen, Germany, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 11/14/17 Warning Letter. Specific violations cited in the letter were: * failing to
Devices
A 5/6-5/11/17 FDA inspection at Curasan AG, Frankfurt, Germany, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Cerasorb Dental, Cerasorb M Dental, Cerasorb Perio, Revios Implant System, IngeniOs HA (Osborne Dental), IngeniOs Beta-TCP Bioactive (Ceracell Dental), and Cerasorb Ortho
FDA Policy/General
Federal Register notice: FDA has announced a 3/1 Vaccines and Related Biological Products Advisory Committee meeting. During the meeting, panel members will hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology. They will also discuss and make recommendations on the selection of
FDA Policy/General
Federal Register notice: FDA has announced a 4/30 public workshop entitled “Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.’’ The workshop is intended engage with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopedic SMART Devices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has amended a notice about a 3/1 Neurological Devices Panel of the Medical Devices Advisory Committee meeting to reflect a change in the procedure portion of the document. It is now changed to read as follows: Procedure: FDA will work with affected industry organizations that
FDA Policy/General
Federal Register notice: CDER has proposed to refuse approval of a Pharmaceutical Manufacturing Research Services (PMRS) NDA for oxycodone hydrochloride immediate-release oral capsules. The notice summarizes the grounds for the not approving the submission and offers PMRS an opportunity to request a hearing on the matter. On 11/16/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bayer AG Leverkusen, Germany (11/14/2017): FDA inspected the facility 1/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish and
Drugs
GE Healthcare says it recognizes and appreciates FDA efforts to bring clarity and the appropriate level of regulatory oversight to clinical and patient decision support software, but is concerned that some language in a draft guidance “raises some questions and uncertainty regarding scope and extent of the proposed level of
Drugs
Three stakeholders say FDA could improve its draft guidance on a collaborative approach for drug development to be used in pediatric rare diseases that uses Gaucher disease as a model. The National Organization for Rare Diseases (NORD) says that much of the draft guidance is very specific to Gaucher disease
Drugs
Sen. Claire McCaskill (D-MO), ranking Democrat on the Senate Homeland Security and Government Affairs Committee, has released a report alleging the opioid manufacturers have made millions of dollars in payments to advocacy organizations and affiliated individuals that have advocated for broad use of opioids in pain management. “The pharmaceutical
Drugs
Public Citizen has supplemented its 11/15/17 petition asking FDA to require removal from the market of all medications containing olmesartan medoxomil, an angiotensin II receptor blocker (ARB), due to risk of sprue-like enteropathy. The 2/1 supplement cites a large cohort study published in Alimentary Pharmacology and
FDA Policy/General
FDA commissioner Scott Gottlieb says the administration’s budget request provides the agency with the resources to continue to fund its current programs at consistent levels and also seeks $400 million in additional funding “to advance planned initiatives to further promote innovation and competition and advance the health and safety
Drugs
A 9/18-9/22/17 FDA inspection at Cosmecca Korea, Chungcheongbuk-do, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/2 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,