Drugs
A 12/17/19-1/7/20 FDA inspection at Acella Pharmaceuticals, Alpharetta, GA, found significant violations of current good manufacturing practice (CGMP) and other regulations in the firm’s production of finished drugs. An 8/14 Warning Letter says the firm’s NP Thyroid drug product is an unapproved
Drugs
Novo Nordisk responds to an FDA draft guidance, Orange Book Questions and Answers, with the observation that the agency does not address the status of authorized generic applications in its answer to a question about which applications are not listed in the Orange Book. The company says that those not
Drugs
An assessment of combination product review practices under PDUFA 6 indicates that the practices are generally considered by the product sponsors and agency reviewers to be effective and efficient despite some challenges. The just-released 8/7 assessment by Lexington, MA-based Eastern Research Group, Inc. says: * request for determination
Drugs
Timothy Baxter, the former global medical director of Indivior (formerly Reckitt Benckiser) pleaded guilty in a Virginia federal court to a one-count misdemeanor information charging that he caused introduction into interstate commerce of the misbranded drug Suboxone Film. The company’s former CEO recently entered a guilty plea to
Drugs
FDA has issued a guidance, Control of Nitrosamine Impurities in Human Drugs, recommending steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine impurities. FDA says the
Drugs
FDA commissioner Stephen Hahn needs to hold a press conference and tell the truth about how he was pressured to misrepresent (see earlier story) the effectiveness of convalescent plasma or resign, according to widely acclaimed researcher and Scripps Research Translational Institute director Eric Topol. In an open letter to Hahn,
Drugs
Attorneys General from 23 states and territories are asking FDA to prohibit the use of the Orange Book to block competition. Montana attorney general Tim Fox said the Orange Book “enables the branded drug manufacturer to obtain an automatic 30-month suspension of FDA’s approval of any potential generic
Drugs
FDA has approved an Innocoll Holdings Limited NDA for Xaracoll (bupivacaine hydrochloride) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. The company describes Xaracoll as a unique, non-injectable drug-device combination in the form of a bioresorbable collagen implant containing
Drugs
As several Covid-19 vaccines move into final safety-efficacy demonstrations, FDA commissioner Stephen Hahn says it is possible that an emergency use authorization (EUA) could be granted before Phase 3 clinical trials are completed. In an interview with the Financial Times, Hahn said such actions will be transparent, grounded
Drugs
FDA has published new product-specific guidances (PSGs) that provide recommendations for developing generic drugs and generating data needed to support ANDA approval. The latest batch include 19 new and 17 revised PSGs. Specifically, FDA is revising the PSG on liposomal amphotericin B injection, an antifungal used to treat fungal
Drugs
FDA commissioner Stephen Hahn has removed newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 he made at an 8/23 White House press conference. Miller was installed at FDA by the White House less than two
Drugs
FDA has approved a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older. The approval represents the first new mechanism of action for an acne drug in almost 40 years, the company says. The drug targets the androgen receptors directly in the skin
Drugs
The Justice Department says Teva is the seventh generic drug manufacturer to be charged with conspiring to fix prices, rig bids, and allocate customers for generic drugs. A department statement says a superseding indictment filed 8/25 in a Pennsylvania federal court alleges that the company participated in three conspiracies
Drugs
The FDA Oncology Center of Excellence and the LUNGevity Foundation have launched a multi-year longitudinal study to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical setting. Project PEER (Understanding the Lung Cancer Patient Experience in the Real-World Setting) seeks to systematically
Biologics
Three law professors from different U.S. universities are joining the chorus of those expressing concern that FDA is under too much political pressure to make positive decisions on products to help resolve the Covid-19 pandemic. In a piece distributed online to be used as an op-ed, the
Drugs
Although Stericycle predicted a drop in product recalls during the Covid-19 shutdown of the U.S. economy that started at the end of the first quarter, recalls continued at their typical level, according to the company’s second-quarter report. The report section on medical devices says those companies
Drugs
FDA has posted final determinations reached in July for three of the nine open drug efficacy study implementation (DESI) proceedings that look at the effectiveness of drugs that had been approved only for safety between 1938 and 1962. The post shows final determinations for pentaerythritol tetranitrate; peripheral vasodilators, Vasodilan (isoxsuprine)
Drugs
FDA has issued a draft guidance, Evaluating Cancer Drugs in Patients with Central Nervous System Metastases, to give the agency’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients
Drugs
FDA has accepted for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (MEtex14) skipping, as detected by an FDA-approved test.
Drugs
Several stakeholders took advantage of an FDA 7/23 virtual public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) to praise the way PDUFA has worked for the last 30 years and offer suggestions for improvements in the 2022 PDUFA 7 reauthorization agreement. Pharmaceutical Research and
Biologics
Former FDA commissioner Margaret Hamburg and her principal deputy commissioner Joshua Sharfstein are using a Washington Post op-ed to urge the agency to take a firm stance for science and against political pressure and stage managing of agency decisions. The two say President Trump’s 8/23 announcement of
Drugs
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva (FOP). The submission will be based on data from the MOVE trial, a multicenter Phase 3 study. Earlier, dosing in the trial was paused when futility criteria were met