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of regulatory oversight to clinical and patient decision support software, but is concerned that some language in a draft guidance “raises some questions and uncertainty regarding scope and extent of the proposed level of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Three stakeholders say FDA could improve its draft guidance on a collaborative approach for drug development to be used in pediatric rare diseases that uses Gaucher disease as a model. The National Organization for Rare Diseases (NORD) says that much of the draft guidance is very specific to Gaucher disease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,
Devices
FDA has added new information to the labeling of warfarin international normalized ratio (INR) test meters for patients, caregivers and health care providers using the devices at home or in a clinical setting. The agency says it has received Medical Device Reporting-related adverse events about meters which may have
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in patients aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is
FDA Policy/General
FDA stands to gain a $663 million (13%) budget boost in President Trump’s just-released fiscal year (FY) 2019 budget proposal, treatment not afforded most other non-military programs, which face massive cuts in the unlikely event that Congress agrees to all of those reductions. The budget includes $5.
FDA Policy/General
FDA commissioner Scott Gottlieb is getting mostly high marks from agency watchers, unlike many in Trump Administration top posts that have found themselves embroiled in controversy after controversy, according to a New York Times article. “Now, more than nine months after he was confirmed, Dr. Gottlieb has achieved something unusual
Drugs
FDA has released a guidance on Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment that is intended to assist sponsors with pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at an FDA/American
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension request for “Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling” (OMB Control Number 0910-0624). To view the notice, click here.
FDA Policy/General
Federal Register notice: CDER has announced a continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program. Pharmaceutical companies are invited to participate in the program, and those interested should send proposed agendas to the agency by 4/13. To view the notice, click here.
FDA Policy/General
Information Collection Extension for CVM Dispute Resolution Federal Register notice: FDA submits for OMB approval an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine.” 02/09/2018 Information Collection Extension for ADR eSubmission Waivers Federal Register notice: FDA
Drugs
A Washington Legal Foundation brief has urged U.S. Court of Appeals for the Seventh Circuit to reject a “novel theory of liability” that would hold pharmaceutical manufacturers liable for injuries caused by drugs they did not manufacture. In Dolin v. GlaxoSmithKline, Wendy Dolin alleges that her husband’s 2010
Drugs
CDER has launched a new External Stakeholder Meeting Request system for requesting meetings with Center officials on drug development and drug safety matters. “Meetings with patient advocacy groups, health care professionals, and other non-industry stakeholders are invaluable to our work,” the agency says. “They provide a mechanism for communicating
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine — 21 CFR 10.75” (OMB Control Number 0910-0566). To view the notice, click here.
Drugs
FDA has extended by three months the user fee review of Salix Pharmaceuticals’ NDA for Plenvu (NER1006). The new review target date is 5/13, and it gives agency reviewers more time to review additional data that were recently provided at FDA’s request. Plenvu is an investigational, novel, low-
Drugs
FDA has granted Xeris Pharmaceuticals an orphan drug designation for its ready-to-use, liquid-stable glucagon for treating hyperinsulinemic hypoglycemia, a condition in which blood glucose levels become low due to excessive insulin secretion. The designation was granted, in part, on the basis that mini-doses of glucagon may
Devices
Philips Electronics has recalled its HeartStart MRx Defibrillator due to a defect in the device’s gas discharge tube. The tube has micro cracks which allow internal gasses to escape and cause the tubes to not function as expected, an FDA notice says. “This also permits an electrical current surge