Drugs
FDA has issued a draft guidance, Elemental Impurities in Drug Products, with recommendations about controlling elemental impurities of human drug products marketed in the U.S. consistent with implementation of the International Council for Harmonization guidance for industry, Q3D Elemental Impurities. The document says it also will assist manufacturers of
Drugs
FDA has sent a complete response letter (CRL) to Lipocine for its LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The CRL identified deficiencies related to the dosing algorithm for the label, noting
Drugs
FDA has issued two draft guidances to assist sponsors in developing specific types of anti-infective drugs. The first guidance, Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention, addresses the agency’s current thinking about the overall development program and clinical trial designs to support development of drug products
Drugs
Aratana Therapeutics has submitted a new animal drug application for Nocita (bupivacaine liposome injectable suspension), indicated as a local post-operative analgesic for cranial cruciate ligament surgery in dogs. The user fee review target date is 8/28. The company says the drug “lasts up to 72 hours post-surgery
Drugs
Developing a quality metrics program and its new inspection protocol project are two ongoing top priorities for CDER’s Office of Product Quality, according to Office director Michael Kopcha. Speaking at the Drug Information Association’s annual meeting in Philadelphia 6/30, Kopcha said quality metrics will help the agency
Drugs
The Clinical Trials Transformation Initiative (CTTI) has issued new recommendations calling for earlier strategic planning as an important element in clinical trial recruitment. “Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market,
Drugs
Lannett is suing FDA in DC federal court over a 5/17 letter in which the agency rescinded its approval of the company’s ANDA for the oral cancer drug temozolomide (Merck’s Temodar). FDA says that the approval was “mistakenly granted.” At issue is the agency’s recent Warning
Drugs
The 2nd Circuit Court of Appeals has affirmed a lower federal court’s dismissal of antitrust and false advertising claims arising out of Apotex’ ANDA for a generic form of Acorda Therapeutics’ Zanaflex (tizanidine) capsules. Apotex had alleged that Acorda filed a sham petition with FDA to slow Apotex’ generic
Drugs
Bipartisan legislation in both the House and Senate would amend the Controlled Substances Act to ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana, according to four Arent Fox attorneys in an online post. They say the Marijuana Effective Drug Studies (MEDS) Act
Drugs
FDA has created an Oncology Center of Excellence (OCE), which was recommended under the Vice President’s National Cancer Moonshot Initiative, to leverage the combined skills of internal regulatory scientists and reviewers with expertise in drugs, biologics and devices to focus on cancer therapies. CDER Office of Hematology and Oncology
Drugs
A regulatory update by Esperion 6/28 indicated FDA may not accept low density lipoprotein cholesterol (LDL-C) lowering as a surrogate endpoint in Phase 3 studies of the hypercholesterolemia candidate, bempedoic acid (see story). Despite this uncertainty, the agency told FDA Webview 6/29 that it continues to view
Drugs
The health advocacy organization Public Citizen has petitioned FDA to add a Boxed Warning to labeling for six dopamine agonists used in treating Parkinson’s disease and restless leg syndrome for an increased risk of impulse control problems that can lead to pathological gambling, hypersexuality, and compulsive shopping or eating.
Drugs
While CDER’s Office of Prescription Drug Promotion (OPDP) has been relatively quiet in its issuance of Warning and untitled letters the past two years, it appears staffers are probably keeping busy with an increased workload in advertising/promotion (Form 2253) submissions. Last year, OPDP received a total of 96,
Drugs
Hand sanitizers sure make your hands smell fresh and clean, but do they actually work to kill/reduce bacteria on the hands? A new FDA proposed rule is requesting that manufacturers provide additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic
Drugs
AstraZeneca is asking FDA to correct an exclusivity error for its Crestor in the latest Orange Book update. The letter references a 5/31/16 petition that asked the agency not to approve any ANDA or 505(b)(2) application referencing Crestor (rosuvastatin calcium) until expiration of the orphan drug
Drugs
A 3/14-16 FDA inspection at Chongqing Lummy Pharmaceutical Co., Chongqing, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 6/21 Warning Letter. Specific violations noted in the letter included: * failing to prevent unauthorized access or changes to data and failing
Drugs
A 5/4-5/7/15 FDA inspection at Shanghai Desano Chemical Pharmaceutical Co., Shanghai, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 6/16 Warning Letter. Specific deviations cited include: * failing to have laboratory control records that include complete data derived
Drugs
A Massachusetts federal magistrate judge has recommended that a class action suit alleging anticompetitive and racketeering behavior by Ranbaxy and Sun Pharmaceuticals before the entry of two generic drugs on the market should not be dismissed. The complex suit raises issues not tried before and thus there was little precedent
Drugs
AstraZeneca filed suit 6/27 in DC federal court challenging FDA’s interpretation of statutes and regulations that (i) prohibit a generic drug from being marketed unless it includes all pediatric information appearing on the corresponding brand-name drug label, and (ii) allow generic drug manufacturers to “carve out” or
Drugs
FDA says it has approved Gilead’s Epclusa to treat adults who have chronic hepatitis C virus (HCV) either with or without cirrhosis. An agency statement says that it is the first drug regimen to treat all six major HCV genotypes. For patients with moderate to severe cirrhosis, the statement
Drugs
The Generic Pharmaceutical Association says that it agrees with FDA that data should be reliable and accurate. “Good manufacturing practices must be followed and data integrity is a necessary component of a robust quality system,” it says in commenting on an agency draft guidance on data integrity and compliance with
Drugs
FDA has released a draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” that addresses the process for evaluating whether an advisory committee member has potentially disqualifying non-financial interests or relationships. It also describes FDA’s process for determining whether to