The Central Drugs Standard Control Organization (“CDSCO”) has released draft guidelines in an effort to streamline the regulatory process for granting marketing permission to similar vaccines and other biosimilars in India. The proposed revised Guidelines on Similar Biologics, 2016 (“Draft Guidelines”) seek to supplement the earlier “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” (“2012 Guidelines”).
Monthly Archives: April 2016
立法动态 Legislative Updates
General Office of the State Council Releases the Opinions on Strengthening the Management of Permanent Residence Service for Foreigners
The Los Angeles County Board of Supervisors is considering an ordinance that would require pharmaceutical companies to operate and fund a program to collect and safely dispose of unwanted prescription and over-the-counter medications. This program is similar to a program enacted in Alameda County, which the pharmaceutical lobby (“PhRMA”) challenged unsuccessfully up to the United States Supreme Court.
Providing facilities to collect and destroy unwanted medications has important health, safety and environmental benefits: protecting the elderly from drugs they no longer need, protecting youth from using and trafficking in dangerous prescription drugs, and keeping chemicals out of our wastewater and landfill. Even though PhRMA opposed the ordinance in Alameda County, during the litigation they represented to the court that they did not dispute the health, safety and environmental benefits of the ordinance.
The last time you were in a shop you may have seen a sign at the checkout that sets out the store’s returns policy. You may have also noticed that the sign will have had a fairly mysterious phrase, to the effect that the returns policy “does not affect your statutory rights”. Whilst this may be some comfort, people may be hard pressed to explain exactly what this means. This article aims to briefly set out the main rights that ordinary shoppers have if something goes wrong.
On February 17, 2016 the Volgo-Vyatskiy District Commercial Court has published the decision in caseNo. А43-14334/2015.
Under the auspices of the case, the Antitrust department of Nizhny Novgorod region filed a claim against the Government of Nizhny Novgorod region challenging its Decree No. 891 dated on December 17, 2014 “On competence of public enterprise Nizhny Novgorod Pharmacy”.
Two years ago, as we discussed here and here, in NLRB v. Noel Canning, 134 S. Ct. 2550 (2014), the U.S. Supreme Court held unconstitutional President Obama’s January 2012 recess appointments of Members Block, Flynn and Griffin to the National Labor Relations Board (“Board” or “NLRB”). The decision cast into doubt the validity of hundreds of NLRB orders and official actions.
Recently, in Advanced Disposal Services East Inc. v. NLRB, decided April 21, 2016, the employer, Advanced Disposal Services, unsuccessfully attempted to invalidate actions taken by Regional Director Dennis Walsh by arguing the invalid recess appointments meant the Board lacked a quorum when it appointed Walsh as a Regional Director for Philadelphia based Region 4. Advanced claimed Walsh’s appointment was therefore invalid, and he lacked authority to oversee the election involving Advanced’s employees in which those employees elected to be represented by the Teamsters Local No. 384 by a vote of 60-58. Because Walsh’s actions facilitating that election were beyond his power, the election was invalid. Following the Board’s certification of the bargaining unit, Advanced refused to bargain with the union, drawing an unfair labor practice charge.
Legal marketing is more than an art; it’s a science.
Or so says Tom Shapiro of Stratabeat, Inc, who presented one of the four TED Talks during an LMA16 breakout session at the recent Annual Conference in Austin, Texas. According to the session description:
Restrictive covenant agreements are traditionally governed by state law and thus subject to various jurisdictions’ rules regarding enforceability. They stand on a different footing than most other contracts, in that their enforcement is typically susceptible to a court’s equitable powers, and may not always be enforced as written, if at all. States differ on whether their courts will deny enforcement of a restrictive covenant deemed overbroad as written by the parties or instead modify it to meet the particular state’s standards of enforceability. In those states where such modification is authorized, a court may strike out (or “blue pencil”) certain terms of the covenant and, in a few states, even insert or modify provisions as deemed necessary to validate the covenant (known as “equitable reformation”).
In the mobile world, regulators grappled with how best to protect the privacy and security of user information as new technologies continued to emerge, with the Federal Trade Commission (FTC) and Digital Advertising Alliance (DAA) issuing reports, convening workshops, and signaling their intention to increase enforcement.
The FTC’s report on the “Internet of Things” (IoT) recommended steps companies should take to protect users’ security and privacy. The report defined IoT as devices or sensors — other than computers, smartphones, or tablets — that connect, store, or transmit information with or between each other via the Internet.