Drugs
The Federal Trade Commission (FTC) says it is joining with the Justice Department, state attorneys general, the Canadian Competition Bureau, European Commission Directorate General for Competition, and the UK Competition and Markets Authority to form a working group to update their approach to analyzing the effects of pharmaceutical mergers. An
Drugs
FDA has accepted for priority review a Merck NDA for belzutifan for treating patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) that does not require immediate surgery. The NDA is based on data from the Phase 2 Study-004 trial, in which belzutifan showed a confirmed
Drugs
In FY 2020, FDA awarded 11 new research contracts and five new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The FY 2020 GDUFA Science and Research Report from the CDER Office of Generic Drugs and Office of Pharmaceutical Quality says FDA
Devices
KEB consultant Adam Atherton says his analysis of FDA quality system inspection data over time yielded three takeaways to ensure future success. In a Med Device Online guest column, Atherton says agency inspections of medical device quality systems are driven by either the older, but still relevant, quality system inspection
Devices
CDRH says it is providing information to test developers about a streamlined path for emergency use authorization (EUA) for Covid-19 tests and information to assist in setting up testing programs. An online notice (contains links to documents) says FDA issued a new supplemental template for test developers seeking EUA
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for TransMedics’ OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double-lung transplantation. The review period was determined to be 2,341 days,
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for DT MedTech’s Hintermann Series H3 Total Ankle Replacement System, indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a 12/9/2020 notice entitled “Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability.” Comments on the draft guidance should be submitted by 6/14 for the agency to consider them before
Drugs
FDA says its review of records supplied by Foshan Biours Biosciences Co., Guangdong Sheng, China, a registered manufacturer of over-the-counter drug products, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were: * failing to have, for
Drugs
FDA says its review of records supplied by Dibar Nutricional, a Morelia, Michoacan, Mexico, manufacturer of over-the-counter (OTC) drugs, determined significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says the specific violations are: * failing to conduct at least one
FDA Policy/General
Federal Register notice: FDA has announced 5/18-19 public meeting entitled “Potential Medication Error Risks with Investigational Drug Container Labels.” The meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and FDA. It is scheduled to solicit input from stakeholders on the risk of
Drugs
The inaugural annual report for the reorganized CDER Office of New Drugs (OND) says OND was able to meet or exceed its PDUFA goals, approve 53 new drugs, publish 31 new guidances, and maintain regulatory and programmatic operational responsibilities despite a significantly increased workload associated with the Covid-19 pandemic.
Drugs
Alvogen has filed suit in DC federal court asking it to order FDA to approve the firm’s ANDA for buprenorphine film in several strengths and to determine that Teva has forfeited any entitlement to 180-day marketing exclusivity for its buprenorphine film ANDAs. The suit says Alvogen submitted its
Biologics
Leaked documents from a cyberattack at the European Medicines Agency (EMA) late last year provide a rare glimpse into how the regulatory agency and regulators at FDA and Health Canada collaborated on a review issue involving Pfizer-BioNTech’s Covid-19 vaccine. The hacked documents were anonymously sent to The
Drugs
In a 3/12 citizen petition, TherapeuticsMD asks FDA not to receive or approve any marketing application that references Annovera (segesterone acetate and ethinyl estradiol vaginal system) unless several specified conditions are met. The petition says a marketing application: * should only be submitted as an ANDA; * should cover an ANDA
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.” The proposed research by CDER Office of Prescription Drug Promotion will focus on the effect on consumers’ and healthcare providers’ perceptions of a drug product’s name and
FDA Policy/General
Federal Register notice: FDA has announced a 4/27-29 Oncologic Drugs Advisory Committee meeting to hear updates on certain supplemental BLAs that were granted accelerated approval and confirmatory trials have not verified clinical benefit. Panel members are scheduled to discuss Genentech’s Tecentriq (atezolizumab), Merck’s Keytruda (pembrolizumab), and
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Request for Samples and Protocols” (OMB Control Number 0910-0206). The collection pertains to the agency’s authority to require manufacturers of licensed biological products to submit samples of any lot, along with the protocols showing the
Drugs
Sanofi and Regeneron are stopping early a Phase 3 clinical trial on PD-1 inhibitor Libtayo (cemiplimab) based on positive data and now plan an FDA submission later this year for treating cervical cancer. The data showed an overall survival benefit for Libtayo monotherapy compared to chemotherapy in patients previously
Devices
FDA has issued a safety alert on Stryker’s Scandinavian Total Ankle Replacement device due to a higher than expected risk of the device’s polyethylene (plastic) component breaking as early as three to four years after implantation. “Fracture of the plastic component of the STAR Ankle may lead to
Drugs
FDA has issued PharmaEssentia a complete response letter (CRL) on its BLA for ropeginterferon alfa-2b-njft for treating polycythemia vera, a rare blood cancer, requesting the need for additional data about the administration format with the product. “Importantly, no concerns were raised about the clinical profile of the product,
Drugs
FDA has lifted a clinical hold against a Histogen IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage