Drugs
FDA has approved an Orthofix International PMA for its next-generation Physio Stim bone growth stimulator. The device provides a non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. It uses a pulsed electromagnetic field signal to
Drugs
The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) says it welcomes issuance of an FDA draft guidance to assist ANDA applicants by highlighting common, recurring deficiencies in ANDAs and to provide recommendations on how to avoid these and other similar deficiencies with the goal of minimizing the number
Drugs
Sagent Pharmaceuticals has recalled 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-specification impurity results detected during routine quality testing of stability samples for two lots. The impurity has not yet been identified. An elevated impurity has the
Drugs
FDA has approved a TaiMed Biologics BLA for Trogarzo (ibalizumab-uiyk), a new type of antiretroviral for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV). The therapy is
Drugs
A 9/25-9/29/17 FDA inspection at Nan San Pharmaceutical Factory, Hong Kong, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, along with other violations, according to a 2/23 Warning Letter. Specific violations cited in the letter were: * failing to perform for
Drugs
Sen. Tina Smith (D-MN) has introduced the Expanding Access to Low Cost Generic Drugs Act to give FDA authority to act as a federal watchdog over so-called “pay-for-delay” agreements in which an innovator drug company pays a generic drug company to delay entry of its generic
Drugs
The CBER Advertising and Promotional Labeling Branch (APLB) says that a Web site, patient brochure, exhibit panel, and sales aid for CSL Behring’s Idelvion (coagulation Factor IX [recombinant] albumin fusion protein) make misleading claims about the product’s effectiveness, causing the drug to be misbranded. A 2/27 Notice
Drugs
An 8/14-8/18/17 FDA inspection at Zhejiang Ludao Technology Co., Taizhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/23 Warning Letter. Specific violations cited in the letter were: * failing to ensure that laboratory records included complete
Drugs
FDA released 3/6 the FDA-483 issued following a 2/12-2/20 agency inspection at Aurobindo Pharma, Telagana, India. The nine inspection observations on the form are: * · aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions; * · equipment and utensils are
Drugs
FDA released 3/7 the FDA-483 issued following a 2/12-2/23 inspection at Sun Pharmaceutical Industries, Gujarat, India. Specific observations shown on the form were: * separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products; * · written
Drugs
FDA has approved a TaiMed Biologics BLA for Trogarzo (ibalizumab-uiyk), a new type of antiretroviral for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV). The therapy is
Drugs
Washington Legal Foundation (WLF) says the 1st Circuit Court of Appeals should grant a Warner Chilcott motion asking it to reverse a Massachusetts federal court decision granting standing to plaintiffs in antitrust litigation involving the company’s drugs indicated to treat ulcerative colitis. The WLF amicus brief says it is
Drugs
FDA has approved an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmer’s ear) caused by Pseudomonas aeruginosa and Staphylococcus aureus in patients aged six months and older. Otiprio is the first single-dose antibacterial approved by the agency for treating the infection. Topical
Drugs
An FDA review of cancer drugs that used the accelerated approval program has found that very few of the resulting indications failed to verify clinical benefit in required confirmatory trials. The review covered the past 25 years and concluded with high marks for the program, according to agency officials writing
Drugs
CDER Office of Strategic Programs director Theresa Mullin has been promoted effective 3/5 to a new position in Center director Janet Woodcock’s immediate office — associate director for strategic initiatives. In her new role, Mullin will oversee “strategic interest” areas that involve external stakeholders. She will continue to lead
Drugs
Pending right-to-try legislation in Congress, which would give terminally ill patients access to investigational drugs, is an ill-advised political stance that would “circumvent” FDA’s authority and offer patients false hope, according to an online post from Friends of Cancer Research chair and founder Ellen V. Sigal.
Drugs
FDA has issued a safety alert about unapproved products claiming to prevent, treat or cure influenza. “As the flu continues to make people sick — and even cause deaths — unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the
Drugs
Biogen and AbbVie have announced the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis (MS) due to safety concerns, including reports of severe liver damage and immune-related conditions. The companies said that “characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward
Drugs
President Donald Trump wants the federal government to bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair marketing practices to help fuel the U.S opioid abuse crisis. Speaking at a 3/1 White House summit on opioid addiction, Trump said he raised the issue with
Drugs
FDA has accepted for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational drug for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The agency has set a user fee review action target date of 12/20. The submission includes data from a Phase 3 clinical
Drugs
Attorneys David Gibbons and Dara Levy (Hyman, Phelps and McNamara) say that FDA interpretations of regulations on importation of active pharmaceutical ingredients (API) are driving manufacturing of investigational finished drug products outside the U.S. In a post in their firm’s FDA Law Blog, the two write that under
Drugs
FDA has posted an International Council for Harmonization guidance “E18 Genomic Sampling and Management of Genomic Data.” The document is intended to provide harmonized principles for genomic sampling and managing genomic data in clinical studies. It also is structured to facilitate the implementation of genomic studies by enabling a common